TheArtOfService
Back to Frameworks

IEC 62304:2015 Medical Device Software Lifecycle Processes

Self-Assess
International
v2015 (Ed 1.1)
6 domains
30 controls

IEC 62304 defines the lifecycle requirements for the development and maintenance of medical device software. It specifies processes, activities, and tasks for each stage of the software lifecycle including planning, requirements analysis, architectural design, detailed design, unit implementation, integration testing, system testing, release, and maintenance. Software safety classification (Class A, B, C) determines the rigor of required activities.

Verified

Framework summaries on this platform are AI-assisted interpretations for educational and compliance planning purposes. They do not reproduce or replace the official standards. Refer to the authoritative source for the definitive text. Framework names and trademarks belong to their respective organisations.

Framework Domains (6)

Clause 4 — General Requirements

4 controls

Quality management system, risk management, and software safety classification

Controls in the Clause 4 — General Requirements domain of IEC 62304:2015 Medical Device Software Lifecycle Processes — 4 controls
CodeTitle
IEC62304-4.1Quality Management System
IEC62304-4.2Risk Management
IEC62304-4.3Software Safety Classification
IEC62304-4.4Legacy Software

Clause 5 — Software Development Process

8 controls

Complete software development lifecycle from planning through release

Controls in the Clause 5 — Software Development Process domain of IEC 62304:2015 Medical Device Software Lifecycle Processes — 8 controls
CodeTitle
IEC62304-5.1Software Development Planning
IEC62304-5.2Software Requirements Analysis
IEC62304-5.3Software Architectural Design
IEC62304-5.4Software Detailed Design
IEC62304-5.5Software Unit Implementation and Verification
IEC62304-5.6Software Integration and Integration Testing
IEC62304-5.7Software System Testing
IEC62304-5.8Software Release

Clause 6 — Software Maintenance Process

3 controls

Post-market software maintenance, modification, and re-release activities

Controls in the Clause 6 — Software Maintenance Process domain of IEC 62304:2015 Medical Device Software Lifecycle Processes — 3 controls
CodeTitle
IEC62304-6.1Establish Software Maintenance Plan
IEC62304-6.2Problem and Modification Analysis
IEC62304-6.3Modification Implementation

Clause 7 — Software Risk Management Process

4 controls

Risk management activities specific to software for medical devices

Controls in the Clause 7 — Software Risk Management Process domain of IEC 62304:2015 Medical Device Software Lifecycle Processes — 4 controls
CodeTitle
IEC62304-7.1Analysis of Software Contributing to Hazardous Situations
IEC62304-7.2Risk Control Measures
IEC62304-7.3Verification of Risk Control Measures
IEC62304-7.4Risk Management of Software Changes

Clause 8 — Software Configuration Management Process

3 controls

Configuration identification, change control, and status accounting

Controls in the Clause 8 — Software Configuration Management Process domain of IEC 62304:2015 Medical Device Software Lifecycle Processes — 3 controls
CodeTitle
IEC62304-8.1Configuration Identification
IEC62304-8.2Change Control
IEC62304-8.3Configuration Status Accounting

Clause 9 — Software Problem Resolution Process

8 controls

Detection, reporting, evaluation, and resolution of software problems

Controls in the Clause 9 — Software Problem Resolution Process domain of IEC 62304:2015 Medical Device Software Lifecycle Processes — 8 controls
CodeTitle
IEC62304-9.1Prepare Problem Reports
IEC62304-9.2Investigate the Problem
IEC62304-9.3Advise Relevant Parties
IEC62304-9.4Use Change Control Process
IEC62304-9.5Maintain Records
IEC62304-9.6Analyze Problems for Trends
IEC62304-9.7Verify Software Problem Resolution
IEC62304-9.8Test Documentation

Maps to 512 other frameworks

30 total controls
TISAX — Trusted Information Security Assessment Exchange
9 source controls mapped|5 target controls covered
30%
ICH Q10 — Pharmaceutical Quality System
9 source controls mapped|6 target controls covered
30%
EIOPA Guidelines on ICT Security and Governance (2020)
8 source controls mapped|5 target controls covered
27%
EBA Guidelines on ICT and Security Risk Management (EBA/GL/2019/04)
8 source controls mapped|5 target controls covered
27%
EU GMP Annex 11 — Computerised Systems
8 source controls mapped|4 target controls covered
27%
EDM Council DCAM — Data Management Capability Assessment Model
8 source controls mapped|5 target controls covered
27%
NIST SP 800-82 Rev 3 — Guide to OT Security
8 source controls mapped|6 target controls covered
27%
SSAE 18 — Attestation Standards (SOC Reporting)
8 source controls mapped|5 target controls covered
27%
PAS 1192-5:2015 — Security-Minded Approach to BIM and Digital Built Environments
8 source controls mapped|4 target controls covered
27%
Canada ITSG-33 — IT Security Risk Management
8 source controls mapped|4 target controls covered
27%
New Zealand Information Security Manual (NZISM)
8 source controls mapped|4 target controls covered
27%
MARS-E — Minimum Acceptable Risk Standards for Exchanges
8 source controls mapped|4 target controls covered
27%
South Korea Cloud Security Assurance Program (CSAP)
8 source controls mapped|4 target controls covered
27%
NRC 10 CFR 73.54 — Nuclear Facility Cybersecurity
8 source controls mapped|6 target controls covered
27%
CFTC System Safeguards (17 CFR 37, 38, 39, 49)
8 source controls mapped|4 target controls covered
27%
DO-178C / ED-12C — Software Considerations in Airborne Systems
8 source controls mapped|9 target controls covered
27%
NIST SP 800-171A Rev 3 — Assessing CUI Security Requirements
7 source controls mapped|10 target controls covered
23%
AS9100D:2016 — Quality Management Systems for Aviation, Space, and Defence
7 source controls mapped|10 target controls covered
23%
AS9100D — Aerospace Quality Management System
7 source controls mapped|10 target controls covered
23%
ISO/IEC 27003:2017
7 source controls mapped|10 target controls covered
23%
BS 65000:2014 — Guidance on Organizational Resilience
7 source controls mapped|6 target controls covered
23%
PIC/S Guide to Good Manufacturing Practice for Medicinal Products
7 source controls mapped|9 target controls covered
23%
ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence
7 source controls mapped|10 target controls covered
23%
IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2)
7 source controls mapped|2 target controls covered
23%
ISO 28001:2007 Supply Chain Security Management
7 source controls mapped|5 target controls covered
23%
South Korea ISMS-P
7 source controls mapped|4 target controls covered
23%
ISO 20400:2017 — Sustainable Procurement
7 source controls mapped|4 target controls covered
23%
CISA ICS-CERT Advisories and Industrial Control Systems Security Guidelines
7 source controls mapped|4 target controls covered
23%
CAIQ (CSA)
7 source controls mapped|4 target controls covered
23%
Azure Security Benchmark
7 source controls mapped|4 target controls covered
23%
C5 (Germany)
7 source controls mapped|4 target controls covered
23%
AWS Well-Architected Security Pillar
7 source controls mapped|4 target controls covered
23%
MTCS (Singapore)
7 source controls mapped|4 target controls covered
23%
ISO 27017
7 source controls mapped|4 target controls covered
23%
ISMAP (Japan)
7 source controls mapped|4 target controls covered
23%
NIST SP 800-145
7 source controls mapped|4 target controls covered
23%
NIST SP 800-190
7 source controls mapped|4 target controls covered
23%
NIST SP 800-146
7 source controls mapped|4 target controls covered
23%
NIST SP 800-144
7 source controls mapped|4 target controls covered
23%
ISO 27018
7 source controls mapped|4 target controls covered
23%
ISO 26262:2018 — Functional Safety for Road Vehicles
7 source controls mapped|3 target controls covered
23%
HKMA SPM
6 source controls mapped|5 target controls covered
20%
ISO/IEC 27557:2022 — Organisational Privacy Risk Management
6 source controls mapped|7 target controls covered
20%
ISO/IEC 23837 — Security Requirements for Quantum Key Distribution
6 source controls mapped|3 target controls covered
20%
FFIEC IT Examination Handbook
6 source controls mapped|5 target controls covered
20%
BCBS 239
6 source controls mapped|5 target controls covered
20%
IEC 60601-1 — Medical Electrical Equipment Safety
6 source controls mapped|4 target controls covered
20%
EU Carbon Border Adjustment Mechanism (CBAM)
6 source controls mapped|5 target controls covered
20%
EU Cyber Solidarity Act (Regulation (EU) 2025/38)
6 source controls mapped|5 target controls covered
20%
EU Digital Services Act — Minors Protection Provisions (Regulation 2022/2065)
6 source controls mapped|4 target controls covered
20%
EU Digital Services Act — Online Gaming Platform Requirements
6 source controls mapped|2 target controls covered
20%
EU Energy Performance of Buildings Directive (EPBD Recast, Directive 2024/1275)
6 source controls mapped|4 target controls covered
20%
EU European Media Freedom Act (EMFA)
6 source controls mapped|6 target controls covered
20%
EU Maritime Single Window Environment Regulation (EU 2019/1239) and EMSA Cybersecurity
6 source controls mapped|6 target controls covered
20%
EU Markets in Crypto-Assets Regulation (MiCA, Regulation 2023/1114)
6 source controls mapped|5 target controls covered
20%
EU Pay Transparency Directive (Directive 2023/970)
6 source controls mapped|7 target controls covered
20%
EU Platform Work Directive (Directive 2024/2831)
6 source controls mapped|7 target controls covered
20%
EU Product Liability Directive (Directive (EU) 2024/2853)
6 source controls mapped|7 target controls covered
20%
EU Seveso III Directive (Directive 2012/18/EU)
6 source controls mapped|6 target controls covered
20%
EU Taxonomy Regulation (Regulation 2020/852)
6 source controls mapped|5 target controls covered
20%
EU Taxonomy Regulation
6 source controls mapped|4 target controls covered
20%
EU Taxonomy for Sustainable Activities (Regulation 2020/852)
6 source controls mapped|3 target controls covered
20%
EU ePrivacy Directive (2002/58/EC)
6 source controls mapped|5 target controls covered
20%
Japan Act on Specified Commercial Transactions (ASCT) — Digital Services
6 source controls mapped|6 target controls covered
20%
Spain Organic Law 3/2018 on Data Protection and Digital Rights (LOPDGDD)
6 source controls mapped|4 target controls covered
20%
African Union Malabo Convention
6 source controls mapped|4 target controls covered
20%
Egypt Personal Data Protection Law (Law No. 151 of 2020)
6 source controls mapped|7 target controls covered
20%
Rwanda Law No. 058/2021 Relating to the Protection of Personal Data
6 source controls mapped|5 target controls covered
20%
Peru Personal Data Protection Law (Law No. 29733)
6 source controls mapped|4 target controls covered
20%
Costa Rica Personal Data Protection Law (Law No. 8968)
6 source controls mapped|5 target controls covered
20%
Turkey Personal Data Protection Law (KVKK — Law No. 6698)
6 source controls mapped|5 target controls covered
20%
Ukraine Law on Personal Data Protection (Law No. 2297-VI)
6 source controls mapped|4 target controls covered
20%
Côte d'Ivoire Law on Personal Data Protection (Law No. 2013-450)
6 source controls mapped|4 target controls covered
20%
Uzbekistan Law on Personal Data (No. ZRU-547)
6 source controls mapped|5 target controls covered
20%
Georgia Law on Personal Data Protection (2012)
6 source controls mapped|5 target controls covered
20%
Colombia Data Protection Law (Law 1581 of 2012 — SIC Oversight)
6 source controls mapped|5 target controls covered
20%
Panama Law on Personal Data Protection (Law No. 81 of 2019)
6 source controls mapped|5 target controls covered
20%
Iceland Data Protection and Processing of Personal Data Act (Act No. 90/2018)
6 source controls mapped|7 target controls covered
20%
Montenegro Law on Personal Data Protection (2023)
6 source controls mapped|7 target controls covered
20%
Lithuania Law on Legal Protection of Personal Data (2018)
6 source controls mapped|3 target controls covered
20%
Romania Law No. 190/2018 on Data Protection Measures (GDPR Implementation)
6 source controls mapped|7 target controls covered
20%
Malta Data Protection Act (Cap. 586, 2018)
6 source controls mapped|7 target controls covered
20%
Oman Personal Data Protection Law (Royal Decree 6/2022)
6 source controls mapped|5 target controls covered
20%
Qatar Personal Data Privacy Protection Law (Law No. 13 of 2016)
6 source controls mapped|5 target controls covered
20%
South Korea Personal Information Protection Act (PIPA)
6 source controls mapped|6 target controls covered
20%
Cambodia Sub-Decree on Personal Data Protection (Sub-Decree No. 134)
6 source controls mapped|7 target controls covered
20%
UNCITRAL Model Law on Electronic Commerce (1996, updated 2005)
6 source controls mapped|5 target controls covered
20%
Brazil Open Finance (Resolução Conjunta No. 1/2020)
6 source controls mapped|6 target controls covered
20%
APRA CPS 234
6 source controls mapped|5 target controls covered
20%
NIST AI Risk Management Framework (AI RMF 1.0)
6 source controls mapped|3 target controls covered
20%
NIST AI 600-1 Generative AI Profile
6 source controls mapped|3 target controls covered
20%
GAMP 5 — Good Automated Manufacturing Practice
6 source controls mapped|6 target controls covered
20%
FAA Cybersecurity Framework for Aviation
6 source controls mapped|9 target controls covered
20%
AASB S2 Climate-related Disclosures
6 source controls mapped|7 target controls covered
20%
Singapore Government Instruction Manual on ICT&SS Management (IM8)
6 source controls mapped|5 target controls covered
20%
TNFD Recommendations
6 source controls mapped|8 target controls covered
20%
ASIC Cyber Resilience Good Practices
6 source controls mapped|5 target controls covered
20%
GLBA
6 source controls mapped|5 target controls covered
20%
EU NIS2 Directive — Energy Sector Cybersecurity Requirements (Directive 2022/2555)
6 source controls mapped|4 target controls covered
20%
OWASP Top 10:2025
6 source controls mapped|3 target controls covered
20%
GLI-33 — Gaming Laboratories International Event Wagering Systems
6 source controls mapped|4 target controls covered
20%
Bermuda Monetary Authority (BMA) Cyber Risk Management Code of Conduct
6 source controls mapped|3 target controls covered
20%
CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0
6 source controls mapped|2 target controls covered
20%
DORA
6 source controls mapped|5 target controls covered
20%
HKMA Cyber Resilience Assessment Framework (C-RAF)
6 source controls mapped|5 target controls covered
20%
IAIS Insurance Core Principles (ICPs)
6 source controls mapped|3 target controls covered
20%
Defence Security Principles Framework (DSPF)
6 source controls mapped|6 target controls covered
20%
Protective Security Policy Framework (PSPF) Release 2024
6 source controls mapped|7 target controls covered
20%
Notifiable Data Breaches Scheme (Australia)
6 source controls mapped|3 target controls covered
20%
EU Digital Markets Act
6 source controls mapped|2 target controls covered
20%
FTC Health Breach Notification Rule
6 source controls mapped|4 target controls covered
20%
UK Product Security and Telecommunications Infrastructure Act (PSTI)
6 source controls mapped|2 target controls covered
20%
EAR — Export Administration Regulations
6 source controls mapped|2 target controls covered
20%
European Accessibility Act (Directive (EU) 2019/882)
6 source controls mapped|2 target controls covered
20%
EU Deforestation-Free Products Regulation (EUDR)
6 source controls mapped|2 target controls covered
20%
Ontario Accessibility for Ontarians with Disabilities Act (AODA) — IASR Web Standard
6 source controls mapped|2 target controls covered
20%
US ITAR and EAR — Export Control and Data Security
6 source controls mapped|2 target controls covered
20%
US SEC Digital Assets and Crypto Regulatory Framework
6 source controls mapped|4 target controls covered
20%
Australia Consumer Data Right — Banking (CDR)
6 source controls mapped|2 target controls covered
20%
Australia eSafety Commissioner — Online Safety Expectations for Industry
6 source controls mapped|2 target controls covered
20%
FBI CJIS Security Policy
6 source controls mapped|4 target controls covered
20%
3GPP Security Architecture (TS 33.501 — 5G Security)
6 source controls mapped|8 target controls covered
20%
FedRAMP Rev 5
6 source controls mapped|10 target controls covered
20%
ISO/IEC 38500:2024 — Governance of IT
6 source controls mapped|4 target controls covered
20%
CSA STAR (Security, Trust, Assurance, and Risk)
6 source controls mapped|3 target controls covered
20%
PCI P2PE
6 source controls mapped|5 target controls covered
20%
OSFI B-13
6 source controls mapped|5 target controls covered
20%
MAS TRM
6 source controls mapped|5 target controls covered
20%
NIS2 Directive Implementing Acts
6 source controls mapped|6 target controls covered
20%
UK Telecommunications (Security) Act 2021
6 source controls mapped|4 target controls covered
20%
Open Banking Security
6 source controls mapped|5 target controls covered
20%
PCI SSF
6 source controls mapped|5 target controls covered
20%
Papua New Guinea National Cybersecurity Policy & Cybercrime Act (2016)
6 source controls mapped|5 target controls covered
20%
Japan FSA Cybersecurity Guidelines for Financial Institutions
6 source controls mapped|5 target controls covered
20%
RBI Cybersecurity Framework for Banks
6 source controls mapped|5 target controls covered
20%
Kuwait National Cybersecurity Framework
6 source controls mapped|5 target controls covered
20%
ECB TIBER-EU
6 source controls mapped|5 target controls covered
20%
Telecommunications Sector Security Reforms (TSSR)
6 source controls mapped|3 target controls covered
20%
MTCS — Multi-Tier Cloud Security (Singapore)
6 source controls mapped|3 target controls covered
20%
SWIFT CSCF
6 source controls mapped|5 target controls covered
20%
NIST Cybersecurity Framework 2.0
6 source controls mapped|6 target controls covered
20%
COSO Enterprise Risk Management (ERM) Framework (2017)
6 source controls mapped|5 target controls covered
20%
AICPA SOC 3
6 source controls mapped|5 target controls covered
20%
ECB TIBER-EU Framework
6 source controls mapped|2 target controls covered
20%
PCI PIN Security
6 source controls mapped|5 target controls covered
20%
AICPA SOC 1
6 source controls mapped|5 target controls covered
20%
ISO 37000:2021 — Governance of Organizations
6 source controls mapped|4 target controls covered
20%
EU Markets in Crypto-Assets Regulation (MiCA)
6 source controls mapped|7 target controls covered
20%
EU PSD3 and Payment Services Regulation (Proposed)
6 source controls mapped|4 target controls covered
20%
PSD2 SCA
6 source controls mapped|5 target controls covered
20%
SWIFT CSP
6 source controls mapped|5 target controls covered
20%
O-RAN Alliance Security Specifications (O-RAN.WG11)
6 source controls mapped|4 target controls covered
20%
ISO/IEC 23894:2023
6 source controls mapped|6 target controls covered
20%
ISO 22320:2018
6 source controls mapped|4 target controls covered
20%
OCC Heightened Standards (12 CFR Part 30, Appendix D)
6 source controls mapped|4 target controls covered
20%
ASD Information Security Manual (ISM)
6 source controls mapped|5 target controls covered
20%
SQF Code Edition 9 — Safe Quality Food
6 source controls mapped|5 target controls covered
20%
BRCGS Global Standard for Food Safety Issue 9
6 source controls mapped|11 target controls covered
20%
ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories
6 source controls mapped|9 target controls covered
20%
FDA Quality Management System Regulation (QMSR)
6 source controls mapped|5 target controls covered
20%
CSA CCM v4
5 source controls mapped|6 target controls covered
17%
Australian Energy Sector Cyber Security Framework (AESCSF)
5 source controls mapped|7 target controls covered
17%
API 1164
5 source controls mapped|4 target controls covered
17%
BIMCO Cyber Security
5 source controls mapped|4 target controls covered
17%
C2M2
5 source controls mapped|4 target controls covered
17%
DO-326A
5 source controls mapped|4 target controls covered
17%
NIST SP 800-53 Rev 5
5 source controls mapped|7 target controls covered
17%
NIST Privacy Framework 1.0
5 source controls mapped|5 target controls covered
17%
NRF Cybersecurity and Data Privacy Framework (National Retail Federation)
5 source controls mapped|7 target controls covered
17%
SOC for Cybersecurity — Cybersecurity Risk Management Examination
5 source controls mapped|4 target controls covered
17%
ISO 27019
5 source controls mapped|4 target controls covered
17%
SASB Standards (ISSB Integrated)
5 source controls mapped|4 target controls covered
17%
SASB Standards
5 source controls mapped|4 target controls covered
17%
IEEE 1686
5 source controls mapped|4 target controls covered
17%
Oman National Cybersecurity Framework
5 source controls mapped|5 target controls covered
17%
IEC 62443
5 source controls mapped|4 target controls covered
17%
NIST SP 1800-32
5 source controls mapped|4 target controls covered
17%
NERC CIP
5 source controls mapped|4 target controls covered
17%
TSA Pipeline Security
5 source controls mapped|4 target controls covered
17%
NIS2 Directive
5 source controls mapped|4 target controls covered
17%
ISO/IEC 27014:2020
5 source controls mapped|4 target controls covered
17%
ILO Nursing Personnel Convention C149 (1977)
5 source controls mapped|6 target controls covered
17%
IATF 16949:2016 — Quality Management System for Automotive Production
5 source controls mapped|4 target controls covered
17%
ASEAN Data Management Framework
5 source controls mapped|5 target controls covered
17%
NIST SP 800-34 Rev 1 — Contingency Planning Guide
5 source controls mapped|4 target controls covered
17%
ISPE GAMP 5 — A Risk-Based Approach to Compliant GxP Computerised Systems
5 source controls mapped|4 target controls covered
17%
ESA ECSS-E-ST-40C — Space Software Engineering Standard
5 source controls mapped|5 target controls covered
17%
ECSS Software Engineering Standards (ESA)
5 source controls mapped|5 target controls covered
17%
HL7 FHIR Security Framework
5 source controls mapped|2 target controls covered
17%
ISO/IEC 27400:2022
5 source controls mapped|4 target controls covered
17%
DAMA-DMBOK2 — Data Management Body of Knowledge (2nd Edition)
5 source controls mapped|3 target controls covered
17%
EU Anti-Money Laundering Directive (AMLD6 / Directive 2018/1673)
5 source controls mapped|8 target controls covered
17%
ICAO Annex 17 — Aviation Security (AVSEC)
5 source controls mapped|4 target controls covered
17%
OWASP DevSecOps Maturity Model (DSOMM)
5 source controls mapped|4 target controls covered
17%
AWWA Cybersecurity Guidance for the Water Sector (American Water Works Association)
5 source controls mapped|2 target controls covered
17%
FATF Recommendation 16 — Virtual Asset Travel Rule
5 source controls mapped|5 target controls covered
17%
ISO 8000 — Data Quality
5 source controls mapped|6 target controls covered
17%
Privacy by Design (PbD) — Seven Foundational Principles
5 source controls mapped|4 target controls covered
17%
ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems
5 source controls mapped|3 target controls covered
17%
US NRC 10 CFR 73.54 — Cyber Security for Nuclear Power Plants
5 source controls mapped|3 target controls covered
17%
PCI DSS v4.0
5 source controls mapped|6 target controls covered
17%
ISO 56002
5 source controls mapped|7 target controls covered
17%
ISO 41001:2018 — Facility Management Systems
5 source controls mapped|6 target controls covered
17%
ISO 39001:2012 — Road Traffic Safety Management
5 source controls mapped|6 target controls covered
17%
ISO 37002:2021 — Whistleblowing Management Systems
5 source controls mapped|6 target controls covered
17%
ISO 50001:2018 — Energy Management Systems
5 source controls mapped|6 target controls covered
17%
ISO 22313:2020 — Guidance on Business Continuity Management Systems
5 source controls mapped|6 target controls covered
17%
ITAR — International Traffic in Arms Regulations
5 source controls mapped|3 target controls covered
17%
SOC 2
5 source controls mapped|3 target controls covered
17%
IRS Publication 1075 — Tax Information Security Guidelines
5 source controls mapped|1 target controls covered
17%
AICPA Privacy Management Framework (PMF)
5 source controls mapped|2 target controls covered
17%
SSAE 18 SOC 1 — Report on Controls at a Service Organisation (ICFR)
5 source controls mapped|2 target controls covered
17%
IAEA Nuclear Security Series — Computer Security at Nuclear Facilities (NSS-17-T Rev 1)
5 source controls mapped|4 target controls covered
17%
UK Gambling Commission — Cyber Resilience Requirements
5 source controls mapped|4 target controls covered
17%
FTC GLBA Safeguards Rule (16 CFR Part 314)
5 source controls mapped|3 target controls covered
17%
SWIFT Customer Security Programme (CSP)
5 source controls mapped|3 target controls covered
17%
Automotive SPICE (ASPICE) v4.0 — Process Assessment Model
5 source controls mapped|3 target controls covered
17%
ISO 14064 — Greenhouse Gas Accounting and Verification (Parts 1-3)
5 source controls mapped|2 target controls covered
17%
COSO ERM
4 source controls mapped|4 target controls covered
13%
Aged Care Quality Standards (Australia)
4 source controls mapped|2 target controls covered
13%
ICH E6(R3) — Good Clinical Practice
4 source controls mapped|3 target controls covered
13%
ISO 27005
4 source controls mapped|4 target controls covered
13%
ISO 31000
4 source controls mapped|4 target controls covered
13%
NIST SP 800-30
4 source controls mapped|4 target controls covered
13%
NIST SP 800-39
4 source controls mapped|4 target controls covered
13%
EASA Part-IS — Information Security in Aviation
4 source controls mapped|4 target controls covered
13%
NIST SP 800-37
4 source controls mapped|4 target controls covered
13%
German Supply Chain Due Diligence Act (LkSG)
4 source controls mapped|2 target controls covered
13%
EU Medical Devices Regulation (MDR 2017/745)
4 source controls mapped|6 target controls covered
13%
ASIS SPC.1-2009 — Organizational Resilience Standard
4 source controls mapped|3 target controls covered
13%
21 CFR Part 211 — Current Good Manufacturing Practice
4 source controls mapped|4 target controls covered
13%
21 CFR Part 58 — Good Laboratory Practice (GLP)
4 source controls mapped|3 target controls covered
13%
US OFAC Sanctions Compliance Framework
4 source controls mapped|4 target controls covered
13%
ISO/IEC 25012:2008 — Data Quality Model
4 source controls mapped|3 target controls covered
13%
ISO/IEC 27006:2024
4 source controls mapped|6 target controls covered
13%
Belgium CyberFundamentals
4 source controls mapped|4 target controls covered
13%
CISA Zero Trust Maturity Model
4 source controls mapped|4 target controls covered
13%
NIST SP 800-171A — Assessing CUI Security Requirements
4 source controls mapped|2 target controls covered
13%
Spain ENS
4 source controls mapped|4 target controls covered
13%
Ghana Cybersecurity Act
4 source controls mapped|3 target controls covered
13%
DoD Zero Trust Reference Architecture
4 source controls mapped|4 target controls covered
13%
BSI IT-Grundschutz
4 source controls mapped|3 target controls covered
13%
CMMC 2.0
4 source controls mapped|4 target controls covered
13%
FISMA
4 source controls mapped|4 target controls covered
13%
ANSSI Cybersecurity Framework
4 source controls mapped|4 target controls covered
13%
Cyber Essentials Plus
4 source controls mapped|4 target controls covered
13%
ISO 30401
4 source controls mapped|2 target controls covered
13%
ISO 37001
4 source controls mapped|2 target controls covered
13%
NIST SP 800-171
4 source controls mapped|4 target controls covered
13%
NIST SP 800-53A
4 source controls mapped|3 target controls covered
13%
ISO 37301
4 source controls mapped|2 target controls covered
13%
NIST SP 800-172
4 source controls mapped|3 target controls covered
13%
ISO 19011
4 source controls mapped|2 target controls covered
13%
ITIL 4
4 source controls mapped|2 target controls covered
13%
ISO 20000-1
4 source controls mapped|2 target controls covered
13%
ISO 27001:2022
4 source controls mapped|3 target controls covered
13%
ISO 55001
4 source controls mapped|2 target controls covered
13%
ISO 9001
4 source controls mapped|4 target controls covered
13%
Saudi NCA ECC
4 source controls mapped|3 target controls covered
13%
Global Cross-Border Privacy Rules (Global CBPR) Forum
3 source controls mapped|1 target controls covered
10%
NIST Privacy Framework Version 1.0
3 source controls mapped|2 target controls covered
10%
Colorado AI Act (SB 24-205)
3 source controls mapped|1 target controls covered
10%
UK ONR Cyber Security and Information Assurance (CSIA) for Nuclear Facilities
3 source controls mapped|1 target controls covered
10%
Critical Infrastructure Risk Management Program (CIRMP) Rules 2023
3 source controls mapped|2 target controls covered
10%
CDP (formerly Carbon Disclosure Project)
3 source controls mapped|4 target controls covered
10%
Brazil AI Framework
3 source controls mapped|3 target controls covered
10%
Singapore Model AI Governance Framework (2nd Edition)
3 source controls mapped|2 target controls covered
10%
China AI Regulations
3 source controls mapped|3 target controls covered
10%
EU AI Act
3 source controls mapped|3 target controls covered
10%
Australia AI Ethics Framework
3 source controls mapped|3 target controls covered
10%
ICMM Mining Principles (2024 Update)
3 source controls mapped|1 target controls covered
10%
BSI C5 — Cloud Computing Compliance Criteria Catalogue
3 source controls mapped|1 target controls covered
10%
AML/CTF Act 2006 (Australia)
3 source controls mapped|1 target controls covered
10%
APRA CPS 220 Risk Management
3 source controls mapped|3 target controls covered
10%
UAE Virtual Asset Regulatory Authority (VARA) Regulations
3 source controls mapped|1 target controls covered
10%
FFIEC Cybersecurity Assessment Tool (CAT)
3 source controls mapped|3 target controls covered
10%
APRA CPS 230 Operational Risk Management
3 source controls mapped|3 target controls covered
10%
UK Defence Standard 05-138 — Cyber Security for Defence Suppliers
3 source controls mapped|2 target controls covered
10%
Canada Artificial Intelligence and Data Act (AIDA)
3 source controls mapped|1 target controls covered
10%
Solvency II
3 source controls mapped|3 target controls covered
10%
IRM Enterprise Risk Management Framework (Institute of Risk Management)
3 source controls mapped|2 target controls covered
10%
OECD AI Principles
3 source controls mapped|3 target controls covered
10%
WCO Authorised Economic Operator (AEO) Framework
3 source controls mapped|3 target controls covered
10%
WCO SAFE Framework of Standards to Secure and Facilitate Global Trade (2021)
3 source controls mapped|3 target controls covered
10%
Customs-Trade Partnership Against Terrorism (C-TPAT)
3 source controls mapped|3 target controls covered
10%
EU Critical Raw Materials Act (Regulation (EU) 2024/1252)
3 source controls mapped|3 target controls covered
10%
EU Chips Act (Regulation (EU) 2023/1781)
3 source controls mapped|3 target controls covered
10%
Singapore AI Governance Framework
3 source controls mapped|3 target controls covered
10%
Own Risk and Solvency Assessment (ORSA) — NAIC Model Act
3 source controls mapped|2 target controls covered
10%
ISO 42001
3 source controls mapped|3 target controls covered
10%
NYDFS Cybersecurity Regulation (23 NYCRR Part 500)
3 source controls mapped|1 target controls covered
10%
UK AI Regulation Framework
3 source controls mapped|3 target controls covered
10%
IEEE 7000
3 source controls mapped|3 target controls covered
10%
APRA SPS 220 Risk Management (Superannuation)
3 source controls mapped|3 target controls covered
10%
Japan AI Guidelines
3 source controls mapped|3 target controls covered
10%
SEC Cybersecurity Disclosure Rules
3 source controls mapped|2 target controls covered
10%
Security of Critical Infrastructure Act 2018 (SOCI)
3 source controls mapped|3 target controls covered
10%
OECD AI Principles (2024 Update)
3 source controls mapped|1 target controls covered
10%
SEC Climate Disclosure Rule
3 source controls mapped|3 target controls covered
10%
Lloyd's of London Cyber Insurance Requirements and Underwriting Standards
3 source controls mapped|1 target controls covered
10%
Authorised Economic Operator (AEO) Programmes — Global Standards
3 source controls mapped|1 target controls covered
10%
IEC 62351 — Power Systems Communication Security
3 source controls mapped|1 target controls covered
10%
ISO/IEC 27004:2016
3 source controls mapped|3 target controls covered
10%
ISO/IEC 29134:2023
3 source controls mapped|3 target controls covered
10%
FCC Customer Proprietary Network Information (CPNI) and Data Breach Rules (47 CFR 64.2001-2011)
3 source controls mapped|3 target controls covered
10%
IFRS 17 — Insurance Contracts
3 source controls mapped|2 target controls covered
10%
CIRCIA (Cyber Incident Reporting for Critical Infrastructure Act)
3 source controls mapped|3 target controls covered
10%
eIDAS 2.0 — EU Digital Identity Regulation
3 source controls mapped|3 target controls covered
10%
MiFID II / MiFIR
3 source controls mapped|1 target controls covered
10%
Ethiopia Personal Data Protection Proclamation (No. 1321/2024)
3 source controls mapped|4 target controls covered
10%
Kazakhstan Law on Personal Data and Their Protection (No. 94-V)
3 source controls mapped|4 target controls covered
10%
Portugal Law No. 58/2019 — Data Protection Implementation Act
3 source controls mapped|6 target controls covered
10%
North Macedonia Law on Personal Data Protection (2020)
3 source controls mapped|5 target controls covered
10%
Uruguay Personal Data Protection Act (Law No. 18.331)
3 source controls mapped|5 target controls covered
10%
Serbia Law on Personal Data Protection (2018)
3 source controls mapped|4 target controls covered
10%
South Korea Korea Internet Self-Governance Organisation (KISO) Code of Ethics
3 source controls mapped|5 target controls covered
10%
Australia NHMRC National Statement on Ethical Conduct in Human Research
3 source controls mapped|2 target controls covered
10%
NAIC Insurance Data Security Model Law (MDL-668)
3 source controls mapped|5 target controls covered
10%
ETSI EN 303 645
3 source controls mapped|1 target controls covered
10%
Austria Data Protection Act (Datenschutzgesetz, DSG, amended 2018)
3 source controls mapped|2 target controls covered
10%
BSIMM
3 source controls mapped|1 target controls covered
10%
DFARS 252.204-7012 — Safeguarding Covered Defense Information
3 source controls mapped|3 target controls covered
10%
Connecticut Data Privacy Act (CTDPA)
3 source controls mapped|3 target controls covered
10%
Illinois Biometric Information Privacy Act (BIPA)
3 source controls mapped|3 target controls covered
10%
Modern Slavery Act 2018 (Australia)
3 source controls mapped|3 target controls covered
10%
COBIT 2019
3 source controls mapped|1 target controls covered
10%
USMCA Chapter 19 — Digital Trade (United States-Mexico-Canada Agreement)
3 source controls mapped|1 target controls covered
10%
OWASP ASVS
3 source controls mapped|1 target controls covered
10%
PCAOB AS 2201 — Audit of Internal Control Over Financial Reporting (ICFR)
3 source controls mapped|3 target controls covered
10%
ISO/IEC 29100:2024
3 source controls mapped|3 target controls covered
10%
ISO/IEC 27011:2024
3 source controls mapped|3 target controls covered
10%
EDM Council CDMC — Cloud Data Management Capabilities Framework
3 source controls mapped|3 target controls covered
10%
NIST Post-Quantum Cryptography Standards (FIPS 203, 204, 205)
3 source controls mapped|1 target controls covered
10%
EN 50126/50128/50129 — Railway RAMS and Safety
3 source controls mapped|3 target controls covered
10%
Angola Personal Data Protection Law (Law No. 22/11)
3 source controls mapped|4 target controls covered
10%
ISO/IEC 29115:2023 — Entity Authentication Assurance Framework
3 source controls mapped|1 target controls covered
10%
EU AI Liability Directive
3 source controls mapped|4 target controls covered
10%
EU General Product Safety Regulation (GPSR, Regulation 2023/988)
3 source controls mapped|5 target controls covered
10%
EU NIS2 Directive — Transport Sector Requirements
3 source controls mapped|2 target controls covered
10%
EU Union Customs Code (UCC) — Data Protection and Security Provisions (Regulation 952/2013)
3 source controls mapped|2 target controls covered
10%
EU Web Accessibility Directive (Directive 2016/2102)
3 source controls mapped|3 target controls covered
10%
Morocco Data Protection Law (09-08)
3 source controls mapped|4 target controls covered
10%
Chile Personal Data Protection Law (Law No. 21.719)
3 source controls mapped|3 target controls covered
10%
Pakistan Personal Data Protection Bill 2023
3 source controls mapped|3 target controls covered
10%
Senegal Law on Personal Data Protection (Law No. 2008-12)
3 source controls mapped|3 target controls covered
10%
Poland Act on Personal Data Protection (Ustawa o ochronie danych osobowych, 2018)
3 source controls mapped|5 target controls covered
10%
Croatia Act on Implementation of the GDPR (Official Gazette 42/2018)
3 source controls mapped|3 target controls covered
10%
Luxembourg Law of 1 August 2018 on Data Protection (GDPR Implementation)
3 source controls mapped|5 target controls covered
10%
RICS Professional Standards — Data and Technology in Property
3 source controls mapped|1 target controls covered
10%
W3C Verifiable Credentials (VC) Data Model 2.0
3 source controls mapped|2 target controls covered
10%
ISO/IEC 27031:2011
3 source controls mapped|1 target controls covered
10%
Belgium Data Protection Act (Wet van 30 juli 2018, Loi du 30 juillet 2018)
3 source controls mapped|2 target controls covered
10%
MITRE D3FEND
3 source controls mapped|1 target controls covered
10%
Science Based Targets initiative (SBTi) Corporate Standard
3 source controls mapped|2 target controls covered
10%
ISO/IEC 27007:2020
3 source controls mapped|1 target controls covered
10%
China Cybersecurity Law (CSL)
3 source controls mapped|1 target controls covered
10%
California IoT Security Law
3 source controls mapped|1 target controls covered
10%
Bosnia and Herzegovina Law on Protection of Personal Data (2006, amended 2011)
3 source controls mapped|3 target controls covered
10%
Albania Law on Protection of Personal Data (Law No. 9887, 2008, amended 2014)
3 source controls mapped|3 target controls covered
10%
Italy Personal Data Protection Code (Legislative Decree No. 196/2003, amended 2018)
3 source controls mapped|1 target controls covered
10%
Kuwait Data Privacy Protection Regulation (KDPPR, 2021 — CMA Directive)
3 source controls mapped|3 target controls covered
10%
Hungary Act CXII of 2011 on Informational Self-Determination and Freedom of Information (Info Act)
3 source controls mapped|4 target controls covered
10%
Paraguay Law on Protection of Personal Data (Law No. 6534/2020)
3 source controls mapped|4 target controls covered
10%
Jordan Draft Personal Data Protection Law (2022)
3 source controls mapped|4 target controls covered
10%
Vietnam Law on Cybersecurity (No. 24/2018/QH14)
3 source controls mapped|5 target controls covered
10%
EU Machinery Regulation (Regulation (EU) 2023/1230)
3 source controls mapped|4 target controls covered
10%
China Personal Information Protection Law (PIPL)
3 source controls mapped|3 target controls covered
10%
Azerbaijan Law on Personal Data (2010)
3 source controls mapped|1 target controls covered
10%
ETSI QKD Standards — Quantum Key Distribution (ETSI ISG QKD)
3 source controls mapped|3 target controls covered
10%
Cook Islands Electronic Transactions Act & Privacy Provisions (2003)
3 source controls mapped|3 target controls covered
10%
US Americans with Disabilities Act (ADA) — Title III Digital Accessibility
3 source controls mapped|3 target controls covered
10%
EU Network Code on Cybersecurity for the Electricity Sector
3 source controls mapped|3 target controls covered
10%
Laos Law on Prevention and Combating Cybercrime (2015)
3 source controls mapped|4 target controls covered
10%
EU Audiovisual Media Services Directive (AVMSD, Directive 2018/1808)
3 source controls mapped|2 target controls covered
10%
EU In Vitro Diagnostic Medical Devices Regulation (IVDR)
3 source controls mapped|2 target controls covered
10%
Lebanon Electronic Transactions and Personal Data Protection Law (Law No. 81/2018)
3 source controls mapped|2 target controls covered
10%
Tunisia Organic Law on Personal Data Protection (Law No. 2004-63)
3 source controls mapped|2 target controls covered
10%
Netherlands GDPR Implementation Act (UAVG — Uitvoeringswet AVG, 2018)
3 source controls mapped|5 target controls covered
10%
Latvia Personal Data Processing Law (Fizisko personu datu apstrades likums, 2018)
3 source controls mapped|7 target controls covered
10%
Finland Data Protection Act (Tietosuojalaki, 1050/2018)
3 source controls mapped|5 target controls covered
10%
Estonia Personal Data Protection Act (Isikuandmete kaitse seadus, 2019)
3 source controls mapped|4 target controls covered
10%
Russia Federal Law on Personal Data (152-FZ)
3 source controls mapped|4 target controls covered
10%
Greece Law 4624/2019 — Hellenic Data Protection Authority (HDPA) Implementation Act
3 source controls mapped|2 target controls covered
10%
Botswana Data Protection Act (2024)
3 source controls mapped|5 target controls covered
10%
Fiji Data Protection Bill (2020)
3 source controls mapped|5 target controls covered
10%
Zimbabwe Data Protection Act (2021)
3 source controls mapped|4 target controls covered
10%
Uganda Data Protection and Privacy Act (2019)
3 source controls mapped|4 target controls covered
10%
ISO/IEC 30111:2019
3 source controls mapped|3 target controls covered
10%
ISO/IEC 29147:2018
3 source controls mapped|3 target controls covered
10%
ISO/IEC 27050 — Electronic Discovery (Parts 1-4)
3 source controls mapped|1 target controls covered
10%
Armenia Law on Protection of Personal Data (2015)
3 source controls mapped|3 target controls covered
10%
EMV 3-D Secure (3DS2) — Payment Authentication Protocol
3 source controls mapped|3 target controls covered
10%
APRA Prudential Standard CPS 234 — Information Security (Australia)
3 source controls mapped|1 target controls covered
10%
Barbados Data Protection Act 2019
3 source controls mapped|1 target controls covered
10%
EU European Health Data Space (EHDS)
3 source controls mapped|1 target controls covered
10%
Switzerland New Federal Act on Data Protection (nFADP/nDSG, 2023)
3 source controls mapped|1 target controls covered
10%
EU Clinical Trials Regulation (CTR 536/2014)
3 source controls mapped|1 target controls covered
10%
South Korea Credit Information Act
3 source controls mapped|1 target controls covered
10%
US Foreign Corrupt Practices Act (FCPA)
3 source controls mapped|1 target controls covered
10%
EU Cyber Resilience Act
3 source controls mapped|1 target controls covered
10%
Digital Economy Partnership Agreement (DEPA)
3 source controls mapped|2 target controls covered
10%
EU Data Act
3 source controls mapped|2 target controls covered
10%
TEFCA — Trusted Exchange Framework and Common Agreement
3 source controls mapped|1 target controls covered
10%
Rhode Island Data Transparency and Privacy Protection Act (RIDTPPA)
3 source controls mapped|3 target controls covered
10%
Wisconsin Data Privacy Act (SB 670)
3 source controls mapped|3 target controls covered
10%
Florida Digital Bill of Rights (FDBR)
3 source controls mapped|3 target controls covered
10%
3GPP 5G Security Architecture (TS 33.501)
3 source controls mapped|2 target controls covered
10%
India Account Aggregator Framework (RBI)
3 source controls mapped|1 target controls covered
10%
3GPP Security
3 source controls mapped|1 target controls covered
10%
SSDF (NIST)
3 source controls mapped|1 target controls covered
10%
UK Bribery Act 2010
3 source controls mapped|3 target controls covered
10%
SANS Incident Handler's Handbook and PICERL Methodology
3 source controls mapped|2 target controls covered
10%
Philippines Cybercrime Prevention Act (RA 10175)
3 source controls mapped|1 target controls covered
10%
NATO STANAG 4774/4778 — Confidentiality Metadata Labels
3 source controls mapped|3 target controls covered
10%
OWASP SAMM
3 source controls mapped|1 target controls covered
10%
ISO 27043
3 source controls mapped|1 target controls covered
10%
WCAG 2.2
3 source controls mapped|1 target controls covered
10%
ISO 22739:2024 — Blockchain and Distributed Ledger Technologies Vocabulary
3 source controls mapped|3 target controls covered
10%
US Children's Online Privacy Protection Act (COPPA) and COPPA 2.0 Proposed Updates
3 source controls mapped|1 target controls covered
10%
NIST SP 800-124 Rev 2 — Mobile Device Security
3 source controls mapped|3 target controls covered
10%
UK Building Safety Act 2022
3 source controls mapped|2 target controls covered
10%
ISO 27002:2022
3 source controls mapped|1 target controls covered
10%
UNECE WP.29 R156
3 source controls mapped|1 target controls covered
10%
Online Safety Act 2021 (Australia)
3 source controls mapped|3 target controls covered
10%
Singapore Payment Services Act (PSA) — Digital Payment Token Regulation
3 source controls mapped|5 target controls covered
10%
Tanzania Personal Data Protection Act (Draft)
3 source controls mapped|4 target controls covered
10%
Trinidad and Tobago Data Protection Act 2011
3 source controls mapped|4 target controls covered
10%
Cayman Islands Data Protection Act 2017 (DPA)
3 source controls mapped|4 target controls covered
10%
Brunei Personal Data Protection Order 2024 (PDPO)
3 source controls mapped|6 target controls covered
10%
Florida Digital Bill of Rights (SB 262)
3 source controls mapped|1 target controls covered
10%
RFC 2350 — Expectations for Computer Security Incident Response (BCP 21)
3 source controls mapped|3 target controls covered
10%
ISO 19650 — Organisation and Digitisation of Information about Buildings and Civil Engineering Works (BIM)
3 source controls mapped|3 target controls covered
10%
South Korea PIPA
3 source controls mapped|1 target controls covered
10%
Bermuda Personal Information Protection Act 2016 (PIPA)
3 source controls mapped|2 target controls covered
10%
UK GDPR (UK General Data Protection Regulation)
3 source controls mapped|1 target controls covered
10%
Australia My Health Records Act 2012
3 source controls mapped|4 target controls covered
10%
Singapore Cybersecurity Act 2018
3 source controls mapped|1 target controls covered
10%
Cyber Security Act 2024 (Australia)
3 source controls mapped|1 target controls covered
10%
UK Open Banking Standard
3 source controls mapped|1 target controls covered
10%
MITRE ATT&CK
3 source controls mapped|1 target controls covered
10%
Virginia Consumer Data Protection Act (VCDPA)
3 source controls mapped|1 target controls covered
10%
Singapore Protection from Online Falsehoods and Manipulation Act (POFMA, 2019)
3 source controls mapped|3 target controls covered
10%
Australia Online Safety Act 2021
3 source controls mapped|4 target controls covered
10%
Jamaica Data Protection Act 2020
3 source controls mapped|3 target controls covered
10%
Mauritius Data Protection Act 2017
3 source controls mapped|2 target controls covered
10%
Kenya Data Protection Act 2019
3 source controls mapped|3 target controls covered
10%
Ghana Data Protection Act 2012 (Act 843)
3 source controls mapped|2 target controls covered
10%
UK Construction (Design and Management) Regulations 2015 (CDM 2015)
3 source controls mapped|3 target controls covered
10%
Denmark Data Protection Act (Databeskyttelsesloven, 2018)
3 source controls mapped|4 target controls covered
10%
Czech Republic Act on Personal Data Processing (Act No. 110/2019 Sb.)
3 source controls mapped|4 target controls covered
10%
South Africa Promotion of Access to Information Act (PAIA)
3 source controls mapped|1 target controls covered
10%
Sweden Data Protection Act (Dataskyddslag, 2018:218)
3 source controls mapped|1 target controls covered
10%
CCSDS 350.0-G-3 — Space Communications Security (Consultative Committee for Space Data Systems)
3 source controls mapped|1 target controls covered
10%
BREEAM — Building Research Establishment Environmental Assessment Method
3 source controls mapped|1 target controls covered
10%
ISO/SAE 21434
3 source controls mapped|1 target controls covered
10%
NIST SP 800-137
3 source controls mapped|1 target controls covered
10%
NIST SP 800-92
3 source controls mapped|1 target controls covered
10%
Nigeria Data Protection Act 2023 (NDPA)
3 source controls mapped|2 target controls covered
10%
NIST SP 800-183
3 source controls mapped|1 target controls covered
10%
OWASP MASVS
3 source controls mapped|1 target controls covered
10%
ITU Radio Regulations and Space Security Standards
3 source controls mapped|1 target controls covered
10%
NIST SP 800-207
3 source controls mapped|1 target controls covered
10%
NIST SP 800-128
3 source controls mapped|1 target controls covered
10%
Israel Protection of Privacy Law (5741-1981)
3 source controls mapped|3 target controls covered
10%
NIST SP 800-160
3 source controls mapped|1 target controls covered
10%
Singapore Payment Services Act 2019 (PSA) — Digital Payment Token Provisions
3 source controls mapped|1 target controls covered
10%
NIST SP 800-88
3 source controls mapped|1 target controls covered
10%
OpenSSF Scorecard
3 source controls mapped|1 target controls covered
10%
Tennessee Information Protection Act (TIPA)
3 source controls mapped|1 target controls covered
10%
NIST SP 800-187
3 source controls mapped|1 target controls covered
10%
NIST SP 800-123
3 source controls mapped|1 target controls covered
10%
NIST SP 800-181
3 source controls mapped|1 target controls covered
10%
NIST SP 800-161
3 source controls mapped|1 target controls covered
10%
PTES
3 source controls mapped|1 target controls covered
10%
UNECE WP.29 R155
3 source controls mapped|1 target controls covered
10%
Regional Comprehensive Economic Partnership (RCEP) — E-Commerce Chapter
3 source controls mapped|2 target controls covered
10%
SIG (Shared Assessments)
3 source controls mapped|1 target controls covered
10%
NIST SP 800-61
3 source controls mapped|1 target controls covered
10%
IATA Operational Safety Audit (IOSA) Standards Manual
3 source controls mapped|1 target controls covered
10%
NIST SP 800-115
3 source controls mapped|1 target controls covered
10%
UK PSTI Act
3 source controls mapped|1 target controls covered
10%
SLSA
3 source controls mapped|1 target controls covered
10%
WHO Global Strategy on Digital Health 2020-2025
3 source controls mapped|1 target controls covered
10%
NIST SP 800-150
3 source controls mapped|1 target controls covered
10%
NIST SP 800-218
3 source controls mapped|1 target controls covered
10%
NIST SP 800-63
3 source controls mapped|1 target controls covered
10%
Sri Lanka Personal Data Protection Act (No. 9 of 2022)
3 source controls mapped|1 target controls covered
10%
French Sapin II Law (Law No. 2016-1691)
3 source controls mapped|1 target controls covered
10%
GLOBALG.A.P. Integrated Farm Assurance (IFA) Standard v6
3 source controls mapped|3 target controls covered
10%
NATO AQAP 2110 — Quality Assurance Requirements for Design, Development, and Production
3 source controls mapped|4 target controls covered
10%
FTC Safeguards Rule (16 CFR Part 314)
2 source controls mapped|1 target controls covered
7%
US Gramm-Leach-Bliley Act (GLBA) — Higher Education Safeguards Rule
2 source controls mapped|1 target controls covered
7%
HIPAA Security Rule
2 source controls mapped|1 target controls covered
7%
IACS Unified Requirements E26/E27 — Cyber Resilience of Ships and On-Board Systems
2 source controls mapped|1 target controls covered
7%
ASD Strategies to Mitigate Cyber Security Incidents
2 source controls mapped|3 target controls covered
7%
CNCF Cloud Native Security (Cloud Native Computing Foundation)
2 source controls mapped|1 target controls covered
7%
OWASP API Security Top 10:2023
2 source controls mapped|1 target controls covered
7%
CISA Secure by Design Principles
2 source controls mapped|1 target controls covered
7%
DISA Security Technical Implementation Guides (STIGs)
2 source controls mapped|3 target controls covered
7%
PropTech Security Standards — Smart Building Cybersecurity
2 source controls mapped|1 target controls covered
7%
UK FCA/PRA Operational Resilience Framework
2 source controls mapped|1 target controls covered
7%
NFPA 1600 — Standard on Continuity, Emergency, and Crisis Management
2 source controls mapped|2 target controls covered
7%
ISO 45001
2 source controls mapped|1 target controls covered
7%
SA8000:2014 — Social Accountability Standard
2 source controls mapped|1 target controls covered
7%
ISO 22000
2 source controls mapped|1 target controls covered
7%
ILO Declaration on Fundamental Principles and Rights at Work (Core Conventions)
2 source controls mapped|1 target controls covered
7%
Voluntary Principles on Security and Human Rights (VPs)
2 source controls mapped|1 target controls covered
7%
EU Better Internet for Kids (BIK+) Strategy
2 source controls mapped|1 target controls covered
7%
C-TPAT — Customs-Trade Partnership Against Terrorism
1 source controls mapped|1 target controls covered
3%
GS1 Global Standards — Supply Chain Traceability and Data Security
1 source controls mapped|2 target controls covered
3%
EU Digital Services Act
1 source controls mapped|1 target controls covered
3%
FSSC 22000 — Food Safety System Certification
1 source controls mapped|3 target controls covered
3%
Compare IEC 62304:2015 Medical Device Software Lifecycle Processes with TISAX — Trusted Information Security Assessment Exchange

Frequently Asked Questions

What is IEC 62304:2015 Medical Device Software Lifecycle Processes?

IEC 62304:2015 Medical Device Software Lifecycle Processes is a compliance framework from International with 6 domains and 30 controls. IEC 62304 defines the lifecycle requirements for the development and maintenance of medical device software. It specifies processes, activities, and tasks for each stage of the software lifecycle including planning, requirements analysis, architectural design, detailed design, unit implementation, integration testing, system testing, release, and maintenance. Software safety classification (Class A, B, C) determines the rigor of required activities. It is used by organisations to establish and maintain compliance with industry standards and regulatory requirements.

How many controls does IEC 62304:2015 Medical Device Software Lifecycle Processes have?

IEC 62304:2015 Medical Device Software Lifecycle Processes has 30 controls organised across 6 domains. The largest domains are Clause 5 — Software Development Process (8 controls), Clause 9 — Software Problem Resolution Process (8 controls), Clause 4 — General Requirements (4 controls). Each control defines specific requirements that organisations must implement to achieve compliance.

What frameworks does IEC 62304:2015 Medical Device Software Lifecycle Processes map to?

IEC 62304:2015 Medical Device Software Lifecycle Processes maps to 512 other compliance frameworks. The top mapping partners are TISAX — Trusted Information Security Assessment Exchange (30% coverage), ICH Q10 — Pharmaceutical Quality System (30% coverage), EIOPA Guidelines on ICT Security and Governance (2020) (27% coverage). Use our comparison tool to explore control-level mappings between frameworks.

How do I get started with IEC 62304:2015 Medical Device Software Lifecycle Processes compliance?

Start your IEC 62304:2015 Medical Device Software Lifecycle Processes compliance journey by running a self-assessment on our platform to identify your current compliance posture. Our AI advisory can answer specific questions about IEC 62304:2015 Medical Device Software Lifecycle Processes requirements, and cross-framework mapping helps you leverage existing controls from other frameworks you may already comply with. Create a free account to access all 30 controls and track your progress.

Start Your Compliance Journey

Create a free account to run self-assessments, get AI advisory, and track your compliance progress across 692 frameworks.

Get Started Free →

Free forever — no credit card required