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IEC 62304:2015 Medical Device Software Lifecycle Processes
International
v2015 (Ed 1.1)
17 domains
50 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.
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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 (17)
Clause 4 - General Requirements
4 controls
Quality management system, risk management, and software safety classification
| Code | Title |
|---|---|
| IEC62304-4.1 | Quality Management System |
| IEC62304-4.2 | Risk Management |
| IEC62304-4.3 | Software Safety Classification |
| IEC62304-4.4 | Legacy Software |
Clause 5 - Software Development Process
8 controls
Complete software development lifecycle from planning through release
| Code | Title |
|---|---|
| IEC62304-5.1 | Software Development Planning |
| IEC62304-5.2 | Software Requirements Analysis |
| IEC62304-5.3 | Software Architectural Design |
| IEC62304-5.4 | Software Detailed Design |
| IEC62304-5.5 | Software Unit Implementation and Verification |
| IEC62304-5.6 | Software Integration and Testing |
| IEC62304-5.7 | Software System Testing |
| IEC62304-5.8 | Software Release |
Clause 6 - Software Maintenance Process
3 controls
Post-market software maintenance, modification, and re-release activities
| Code | Title |
|---|---|
| IEC62304-6.1 | Software Maintenance Plan |
| IEC62304-6.2 | Problem and Modification Analysis |
| IEC62304-6.3 | Modification Implementation |
Clause 7 - Software Risk Management Process
4 controls
Risk management activities specific to software for medical devices
| Code | Title |
|---|---|
| IEC62304-7.1 | Risk Analysis of Software Contributing to Hazardous Situations |
| IEC62304-7.2 | Risk Control Measures |
| IEC62304-7.3 | Verification of Risk Control Measures |
| IEC62304-7.4 | Risk Management of Software Changes |
Clause 8 - Software Configuration Management Process
3 controls
Configuration identification, change control, and status accounting
| Code | Title |
|---|---|
| IEC62304-8.1 | Configuration Identification |
| IEC62304-8.2 | Change Control |
| IEC62304-8.3 | Configuration Status Accounting |
Clause 9 - Software Problem Resolution Process
8 controls
Detection, reporting, evaluation, and resolution of software problems
| Code | Title |
|---|---|
| IEC62304-9.1 | Prepare Problem Reports |
| IEC62304-9.2 | Investigate the Problem |
| IEC62304-9.3 | Advise Relevant Parties |
| IEC62304-9.4 | Use Change Control Process |
| IEC62304-9.5 | Maintain Records |
| IEC62304-9.6 | Analyze Problems for Trends |
| IEC62304-9.7 | Verify Software Problem Resolution |
| IEC62304-9.8 | Test Documentation |
Configuration
3 controls
| Code | Title |
|---|---|
| IEC62304-8.1 | Configuration Identification |
| IEC62304-8.2 | Change Control |
| IEC62304-8.3 | Configuration Status Accounting |
Design
2 controls
| Code | Title |
|---|---|
| IEC62304-5.3 | Software Architectural Design |
| IEC62304-5.4 | Software Detailed Design |
Implementation
1 controls
| Code | Title |
|---|---|
| IEC62304-5.5 | Software Unit Implementation and Verification |
Integration
1 controls
| Code | Title |
|---|---|
| IEC62304-5.6 | Software Integration and Testing |
Maintenance
2 controls
| Code | Title |
|---|---|
| IEC62304-6.1 | Software Maintenance Plan |
| IEC62304-6.2 | Problem and Modification Analysis |
Planning
3 controls
| Code | Title |
|---|---|
| IEC62304-4.3 | Software Safety Classification |
| IEC62304-5.1.1 | Software Development Plan |
| IEC62304-5.1.6 | SOUP Identification |
Problem Resolution
1 controls
| Code | Title |
|---|---|
| IEC62304-9 | Software Problem Resolution Process |
Release
1 controls
| Code | Title |
|---|---|
| IEC62304-5.8 | Software Release |
Requirements
1 controls
| Code | Title |
|---|---|
| IEC62304-5.2 | Software Requirements Analysis |
Risk Management
4 controls
| Code | Title |
|---|---|
| IEC62304-7.1 | Risk Analysis of Software Contributing to Hazardous Situations |
| IEC62304-7.2 | Risk Control Measures |
| IEC62304-7.3 | Verification of Risk Control Measures |
| IEC62304-7.4 | Risk Management of Software Changes |
Verification
1 controls
| Code | Title |
|---|---|
| IEC62304-5.7 | Software System Testing |
Your Compliance Coverage
If you comply with IEC 62304:2015 Medical Device Software Lifecycle Processes, you already cover:
ICH Q10 - Pharmaceutical Quality System
27%
9 controls mapped
Compare →Annex 11 to EU GMP - Computerised Systems
24%
8 controls mapped
Compare →NIST SP 800-82 Revision 3: Guide to Industrial Control Systems (ICS) Security
24%
8 controls mapped
Compare →+ 196 more: MTCS (Singapore) (24%), SSAE 18 - Attestation Standards (SOC Reporting) (24%)
See all 199 mapped frameworks ↓Maps to 199 other frameworks
33 total controls
ICH Q10 - Pharmaceutical Quality System
9 source controls mapped|3 target controls covered
27%
Annex 11 to EU GMP - Computerised Systems
8 source controls mapped|4 target controls covered
24%
NIST SP 800-82 Revision 3: Guide to Industrial Control Systems (ICS) Security
8 source controls mapped|4 target controls covered
24%
MTCS (Singapore)
8 source controls mapped|3 target controls covered
24%
SSAE 18 - Attestation Standards (SOC Reporting)
8 source controls mapped|5 target controls covered
24%
NIST SP 800-146
7 source controls mapped|2 target controls covered
21%
NIST SP 800-145
7 source controls mapped|2 target controls covered
21%
NIST SP 800-144
7 source controls mapped|2 target controls covered
21%
ISMAP (Japan)
7 source controls mapped|3 target controls covered
21%
Azure Security Benchmark
7 source controls mapped|4 target controls covered
21%
AWS Well-Architected Security Pillar
7 source controls mapped|4 target controls covered
21%
ISO 27018
7 source controls mapped|4 target controls covered
21%
ISO 27017
7 source controls mapped|4 target controls covered
21%
ISO 26262:2018 - Functional Safety for Road Vehicles
7 source controls mapped|3 target controls covered
21%
ISO 19011
7 source controls mapped|4 target controls covered
21%
NIST SP 800-190
7 source controls mapped|4 target controls covered
21%
PIC/S Guide to Good Manufacturing Practice for Medicinal Products
7 source controls mapped|6 target controls covered
21%
IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2)
7 source controls mapped|2 target controls covered
21%
NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements
7 source controls mapped|10 target controls covered
21%
AS9100D - Aerospace Quality Management System
7 source controls mapped|8 target controls covered
21%
ISO/IEC 27003:2017
7 source controls mapped|8 target controls covered
21%
ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
7 source controls mapped|13 target controls covered
21%
ISO 20400:2017 - Sustainable Procurement
7 source controls mapped|4 target controls covered
21%
PSD2 SCA
6 source controls mapped|3 target controls covered
18%
OSFI B-13
6 source controls mapped|3 target controls covered
18%
Open Banking Security
6 source controls mapped|3 target controls covered
18%
O-RAN WG11 Security Specification
6 source controls mapped|4 target controls covered
18%
Monetary Authority of Singapore Technology Risk Management Guidelines
6 source controls mapped|3 target controls covered
18%
ISO/IEC 27557:2022 - Organisational Privacy Risk Management
6 source controls mapped|7 target controls covered
18%
ISO/IEC 23837 - Security Requirements for Quantum Key Distribution
6 source controls mapped|3 target controls covered
18%
FFIEC IT Examination Handbook
6 source controls mapped|5 target controls covered
18%
IEC 60601-1 - Medical Electrical Equipment Safety
6 source controls mapped|4 target controls covered
18%
APRA CPS 234
6 source controls mapped|5 target controls covered
18%
NIST AI Risk Management Framework (AI RMF 1.0)
6 source controls mapped|3 target controls covered
18%
IAIS Insurance Core Principles (ICPs)
6 source controls mapped|3 target controls covered
18%
ISO/IEC 38500:2024 - Governance of IT
6 source controls mapped|4 target controls covered
18%
PCI P2PE
6 source controls mapped|5 target controls covered
18%
PCI SSF
6 source controls mapped|5 target controls covered
18%
NIST Cybersecurity Framework 2.0
6 source controls mapped|6 target controls covered
18%
PCI PIN Security
6 source controls mapped|5 target controls covered
18%
ISO 37000:2021 - Governance of Organizations
6 source controls mapped|4 target controls covered
18%
ISO/IEC 23894:2023
6 source controls mapped|6 target controls covered
18%
ISO 28001:2007 Supply Chain Security Management
6 source controls mapped|2 target controls covered
18%
ISO 22320:2018
6 source controls mapped|4 target controls covered
18%
FDA Quality Management System Regulation (QMSR)
6 source controls mapped|5 target controls covered
18%
BRCGS Global Standard for Food Safety Issue 9
6 source controls mapped|7 target controls covered
18%
ISO/IEC 17025:2017 - General Requirements for Testing and Calibration Laboratories
6 source controls mapped|9 target controls covered
18%
SASB Standards
5 source controls mapped|2 target controls covered
15%
NRF Cybersecurity and Data Privacy Framework (National Retail Federation)
5 source controls mapped|2 target controls covered
15%
NIST Privacy Framework
5 source controls mapped|3 target controls covered
15%
NIS2 Directive
5 source controls mapped|2 target controls covered
15%
NERC CIP
5 source controls mapped|2 target controls covered
15%
IEEE 1686
5 source controls mapped|2 target controls covered
15%
FTC GLBA Safeguards Rule (16 CFR Part 314)
5 source controls mapped|2 target controls covered
15%
API 1164
5 source controls mapped|4 target controls covered
15%
IEC 62443
5 source controls mapped|4 target controls covered
15%
ISO 27019
5 source controls mapped|4 target controls covered
15%
NIST SP 800-53 Rev 5
5 source controls mapped|7 target controls covered
15%
SOC 2
5 source controls mapped|3 target controls covered
15%
NIST SP 1800-32
5 source controls mapped|4 target controls covered
15%
ITAR - International Traffic in Arms Regulations
5 source controls mapped|2 target controls covered
15%
IAEA Nuclear Security Series - Computer Security at Nuclear Facilities (NSS-17-T Rev 1)
5 source controls mapped|4 target controls covered
15%
ISO/IEC 27014:2020
5 source controls mapped|4 target controls covered
15%
ISO/IEC 27400:2022
5 source controls mapped|4 target controls covered
15%
DAMA-DMBOK2 - Data Management Body of Knowledge (2nd Edition)
5 source controls mapped|3 target controls covered
15%
AWWA Cybersecurity Guidance for the Water Sector (American Water Works Association)
5 source controls mapped|2 target controls covered
15%
ISO 56002
5 source controls mapped|7 target controls covered
15%
ISO 41001:2018 - Facility Management Systems
5 source controls mapped|6 target controls covered
15%
ISO 39001:2012 - Road Traffic Safety Management
5 source controls mapped|6 target controls covered
15%
ISO 37002:2021 - Whistleblowing Management Systems
5 source controls mapped|6 target controls covered
15%
ISO 22313:2020 - Guidance on Business Continuity Management Systems
5 source controls mapped|6 target controls covered
15%
AICPA Privacy Management Framework (PMF)
5 source controls mapped|2 target controls covered
15%
Automotive SPICE (ASPICE) v4.0 - Process Assessment Model
5 source controls mapped|3 target controls covered
15%
ISO 14064 - Greenhouse Gas Accounting and Verification (Parts 1-3)
5 source controls mapped|2 target controls covered
15%
NIST SP 800-171A - Assessing Security Requirements for Controlled Unclassified Information (CUI)
4 source controls mapped|2 target controls covered
12%
BSI IT-Grundschutz
4 source controls mapped|3 target controls covered
12%
ISO 30401
4 source controls mapped|2 target controls covered
12%
ISO 37001
4 source controls mapped|2 target controls covered
12%
ISO 37301
4 source controls mapped|2 target controls covered
12%
ITIL 4
4 source controls mapped|2 target controls covered
12%
ISO 20000-1
4 source controls mapped|2 target controls covered
12%
ISO 55001
4 source controls mapped|2 target controls covered
12%
ISO 9001
4 source controls mapped|4 target controls covered
12%
German Supply Chain Due Diligence Act (LkSG)
4 source controls mapped|2 target controls covered
12%
NIST SP 800-39
4 source controls mapped|2 target controls covered
12%
NIST SP 800-37
4 source controls mapped|2 target controls covered
12%
NIST SP 800-30
4 source controls mapped|3 target controls covered
12%
Aged Care Quality Standards (Australia)
4 source controls mapped|2 target controls covered
12%
ISO 27005
4 source controls mapped|5 target controls covered
12%
ISO 31000
4 source controls mapped|4 target controls covered
12%
EASA Part-IS - Information Security in Aviation
4 source controls mapped|4 target controls covered
12%
21 CFR Part 211 - Current Good Manufacturing Practice
4 source controls mapped|4 target controls covered
12%
21 CFR Part 58 - Good Laboratory Practice (GLP)
4 source controls mapped|3 target controls covered
12%
ISO/IEC 25012:2008 - Data Quality Model
4 source controls mapped|3 target controls covered
12%
ISO/IEC 27006:2024
4 source controls mapped|6 target controls covered
12%
UK AI Regulation Framework
3 source controls mapped|1 target controls covered
9%
SEC Climate Disclosure Rule
3 source controls mapped|1 target controls covered
9%
Own Risk and Solvency Assessment (ORSA) - NAIC Model Act
3 source controls mapped|1 target controls covered
9%
OECD Recommendation on Artificial Intelligence (2024 Update)
3 source controls mapped|1 target controls covered
9%
OECD AI Principles
3 source controls mapped|2 target controls covered
9%
OCC Heightened Standards (12 CFR Part 30, Appendix D)
3 source controls mapped|2 target controls covered
9%
NIS2 Directive Implementing Acts
3 source controls mapped|1 target controls covered
9%
New Zealand Information Security Manual (NZISM)
3 source controls mapped|1 target controls covered
9%
Lloyd's of London Cyber Insurance Requirements and Underwriting Standards
3 source controls mapped|1 target controls covered
9%
Japan AI Guidelines
3 source controls mapped|3 target controls covered
9%
IRM Enterprise Risk Management Framework (Institute of Risk Management)
3 source controls mapped|1 target controls covered
9%
IEEE 7000
3 source controls mapped|2 target controls covered
9%
ICAO Annex 17 - Aviation Security (AVSEC)
3 source controls mapped|2 target controls covered
9%
AS9100D:2016 - Quality Management Systems for Aviation, Space, and Defence
3 source controls mapped|3 target controls covered
9%
BS 65000:2014 - Guidance on Organizational Resilience
3 source controls mapped|2 target controls covered
9%
AML/CTF Act 2006 (Australia)
3 source controls mapped|1 target controls covered
9%
FFIEC Cybersecurity Assessment Tool (CAT)
3 source controls mapped|3 target controls covered
9%
APRA CPS 230 Operational Risk Management
3 source controls mapped|3 target controls covered
9%
FBI CJIS Security Policy
3 source controls mapped|2 target controls covered
9%
APRA SPS 220 Risk Management (Superannuation)
3 source controls mapped|3 target controls covered
9%
Authorised Economic Operator (AEO) Programmes - Global Standards
3 source controls mapped|1 target controls covered
9%
WCAG 2.2
3 source controls mapped|1 target controls covered
9%
UK Gambling Commission - Cyber Resilience Requirements
3 source controls mapped|2 target controls covered
9%
UK GDPR (UK General Data Protection Regulation)
3 source controls mapped|1 target controls covered
9%
Regional Comprehensive Economic Partnership (RCEP) - E-Commerce Chapter
3 source controls mapped|1 target controls covered
9%
UK Bribery Act 2010
3 source controls mapped|1 target controls covered
9%
Trinidad and Tobago Data Protection Act 2011
3 source controls mapped|3 target controls covered
9%
Tanzania Personal Data Protection Act (Draft)
3 source controls mapped|2 target controls covered
9%
SLSA
3 source controls mapped|1 target controls covered
9%
SIG (Shared Assessments)
3 source controls mapped|1 target controls covered
9%
PTES
3 source controls mapped|1 target controls covered
9%
Philippines Cybercrime Prevention Act (RA 10175)
3 source controls mapped|1 target controls covered
9%
OWASP SAMM
3 source controls mapped|1 target controls covered
9%
OWASP MASVS
3 source controls mapped|1 target controls covered
9%
OpenSSF Scorecard
3 source controls mapped|1 target controls covered
9%
NRC 10 CFR 73.54 - Nuclear Facility Cybersecurity
3 source controls mapped|2 target controls covered
9%
Notifiable Data Breaches Scheme (Australia)
3 source controls mapped|1 target controls covered
9%
NIST SP 800-92
3 source controls mapped|1 target controls covered
9%
NIST SP 800-88
3 source controls mapped|1 target controls covered
9%
NIST SP 800-63-4
3 source controls mapped|1 target controls covered
9%
NIST SP 800-61
3 source controls mapped|1 target controls covered
9%
NIST SP 800-137
3 source controls mapped|1 target controls covered
9%
NIST SP 800-123
3 source controls mapped|1 target controls covered
9%
NIST SP 800-115 (Technical Guide to Information Security Testing and Assessment)
3 source controls mapped|1 target controls covered
9%
Nigeria Data Protection Act 2023 (NDPA)
3 source controls mapped|3 target controls covered
9%
Nebraska Data Privacy Act
3 source controls mapped|3 target controls covered
9%
NATO STANAG 4774 (Confidentiality Metadata Labels) and STANAG 4778 (Metadata Binding)
3 source controls mapped|2 target controls covered
9%
MITRE ATT&CK
3 source controls mapped|1 target controls covered
9%
South Korea PIPA
3 source controls mapped|1 target controls covered
9%
ITU Radio Regulations and Space Security Standards
3 source controls mapped|1 target controls covered
9%
Israel Protection of Privacy Law (5741-1981)
3 source controls mapped|2 target controls covered
9%
IATA Operational Safety Audit (IOSA) Standards Manual
3 source controls mapped|1 target controls covered
9%
French Sapin II Law (Law No. 2016-1691)
3 source controls mapped|1 target controls covered
9%
Florida Digital Bill of Rights (FDBR)
3 source controls mapped|1 target controls covered
9%
IEC 62351 - Power Systems Communication Security
3 source controls mapped|1 target controls covered
9%
ISO/IEC 27004:2016
3 source controls mapped|3 target controls covered
9%
ISO/IEC 29134:2023
3 source controls mapped|3 target controls covered
9%
Austria Data Protection Act (Datenschutzgesetz, DSG, amended 2018)
3 source controls mapped|2 target controls covered
9%
Illinois Biometric Information Privacy Act (BIPA)
3 source controls mapped|3 target controls covered
9%
COBIT 2019
3 source controls mapped|1 target controls covered
9%
ISO/IEC 29100:2024
3 source controls mapped|3 target controls covered
9%
ISO/IEC 27011:2024
3 source controls mapped|3 target controls covered
9%
ISO/IEC 29115:2023 - Entity Authentication Assurance Framework
3 source controls mapped|1 target controls covered
9%
ISO/IEC 27031:2011
3 source controls mapped|1 target controls covered
9%
ISO/IEC 27007:2020
3 source controls mapped|1 target controls covered
9%
Albania Law on Protection of Personal Data (Law No. 9887, 2008, amended 2014)
3 source controls mapped|2 target controls covered
9%
ISO 31000:2018
3 source controls mapped|1 target controls covered
9%
Azerbaijan Law on Personal Data (2010)
3 source controls mapped|1 target controls covered
9%
ISO/IEC 30111:2019
3 source controls mapped|3 target controls covered
9%
ISO/IEC 29147:2018
3 source controls mapped|3 target controls covered
9%
CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0
3 source controls mapped|1 target controls covered
9%
ISO/IEC 27050 - Electronic Discovery (Parts 1-4)
3 source controls mapped|1 target controls covered
9%
ASIS SPC.1-2009 - Organizational Resilience Standard
3 source controls mapped|1 target controls covered
9%
Barbados Data Protection Act 2019
3 source controls mapped|1 target controls covered
9%
FedRAMP High
3 source controls mapped|1 target controls covered
9%
NIST SP 800-53 Revision 5.1 HIGH
3 source controls mapped|1 target controls covered
9%
FedRAMP Moderate
3 source controls mapped|1 target controls covered
9%
NIST SP 800-53 Rev 5 MODERATE
3 source controls mapped|1 target controls covered
9%
NIST SP 800-53 Rev 5 LOW
3 source controls mapped|1 target controls covered
9%
SANS Incident Handler's Handbook and PICERL Methodology
3 source controls mapped|2 target controls covered
9%
ISO 27043
3 source controls mapped|1 target controls covered
9%
ISO 22739:2024 - Blockchain and Distributed Ledger Technologies Vocabulary
3 source controls mapped|3 target controls covered
9%
NIST SP 800-124 Revision 2 - Guidelines for Managing the Security of Mobile Devices
3 source controls mapped|3 target controls covered
9%
ISO 19650 - Organisation and Digitisation of Information about Buildings and Civil Engineering Works (BIM)
3 source controls mapped|3 target controls covered
9%
ISO 8000 - Data Quality
3 source controls mapped|2 target controls covered
9%
ISO/SAE 21434
3 source controls mapped|1 target controls covered
9%
Rhode Island Data Transparency and Privacy Protection Act (RIDTPPA)
3 source controls mapped|1 target controls covered
9%
Secure by Design: A Guide for Manufacturers (CISA)
2 source controls mapped|1 target controls covered
6%
Oman National Cybersecurity Framework
2 source controls mapped|1 target controls covered
6%
ASD Strategies to Mitigate Cyber Security Incidents
2 source controls mapped|3 target controls covered
6%
Canada ITSG-33 - IT Security Risk Management
2 source controls mapped|1 target controls covered
6%
Voluntary Principles on Security and Human Rights (VPs)
2 source controls mapped|1 target controls covered
6%
UK FCA/PRA Operational Resilience Framework
2 source controls mapped|1 target controls covered
6%
TISAX - Trusted Information Security Assessment Exchange
2 source controls mapped|1 target controls covered
6%
SA8000:2014 - Social Accountability Standard
2 source controls mapped|1 target controls covered
6%
ILO Declaration on Fundamental Principles and Rights at Work (Core Conventions)
2 source controls mapped|1 target controls covered
6%
NFPA 1600 - Standard on Continuity, Emergency, and Crisis Management
2 source controls mapped|2 target controls covered
6%
ISO 45001
2 source controls mapped|1 target controls covered
6%
ISO 22000
2 source controls mapped|1 target controls covered
6%
ISO 10007:2017
1 source controls mapped|1 target controls covered
3%
ISO 22000:2018
1 source controls mapped|1 target controls covered
3%
ISO 13485
1 source controls mapped|1 target controls covered
3%
ISO 13485:2016
1 source controls mapped|1 target controls covered
3%
ISO 9001:2015
1 source controls mapped|1 target controls covered
3%
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 17 domains and 50 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 50 controls organised across 17 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 199 other compliance frameworks. The top mapping partners are ICH Q10 - Pharmaceutical Quality System (27% coverage), Annex 11 to EU GMP - Computerised Systems (24% coverage), NIST SP 800-82 Revision 3: Guide to Industrial Control Systems (ICS) Security (24% 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 50 controls and track your progress.
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