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ISO 13485
International
v2016
10 domains
29 controls
Medical devices - Quality management systems
Unverified
ISO 13485 is a compliance framework from International with 10 domains and 29 controls that map to 269 other frameworks. The largest domains are ISO 13485: Administrative Safeguards (6 controls), ISO 13485: Patient Data Protection (5 controls), ISO 13485: Technical Safeguards (5 controls). Every control below carries what it requires and what an assessor expects to see.
Maintained by Gerard BlokdykControl text last updated
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 (10)
ISO 13485: Administrative Safeguards
6 controls
Organizational security management (ISO 13485)
| Code | Title |
|---|---|
| ISO13485-06 | Security management process and risk analysis |
| ISO13485-07 | Workforce security and clearance procedures |
| ISO13485-08 | Information access management |
| ISO13485-09 | Security awareness and training program |
| ISO13485-10 | Contingency planning for ePHI |
| ISO13485-11 | Business associate management |
ISO 13485: Organizational Requirements
4 controls
Policies, procedures, and documentation (ISO 13485)
| Code | Title |
|---|---|
| ISO13485-21 | Security and privacy policies |
| ISO13485-22 | Documentation and record retention |
| ISO13485-23 | Compliance evaluation and review |
| ISO13485-24 | Incident reporting procedures |
ISO 13485: Patient Data Protection
5 controls
Safeguarding protected health information (ISO 13485)
| Code | Title |
|---|---|
| ISO13485-01 | ePHI access controls and authorization |
| ISO13485-02 | ePHI encryption at rest and in transit |
| ISO13485-03 | Minimum necessary standard enforcement |
| ISO13485-04 | Patient data de-identification procedures |
| ISO13485-05 | Audit trail for ePHI access |
ISO 13485: Physical Safeguards
4 controls
Physical security for systems with ePHI (ISO 13485)
| Code | Title |
|---|---|
| ISO13485-17 | Facility access controls |
| ISO13485-18 | Workstation security and use policies |
| ISO13485-19 | Device and media controls |
| ISO13485-20 | Disposal and re-use procedures |
ISO 13485: Technical Safeguards
5 controls
Technical measures for ePHI protection (ISO 13485)
| Code | Title |
|---|---|
| ISO13485-12 | Unique user identification and authentication |
| ISO13485-13 | Automatic logoff and session management |
| ISO13485-14 | Audit controls and monitoring |
| ISO13485-15 | Integrity controls for ePHI |
| ISO13485-16 | Transmission security and encryption |
Improvement
1 controls
| Code | Title |
|---|---|
| 8.5 | Control effectiveness review |
Management Responsibility
1 controls
| Code | Title |
|---|---|
| 5.6 | Monitoring Audit Programme |
Measurement
1 controls
| Code | Title |
|---|---|
| 8.3 | Statement of Applicability linkage |
Product Realisation
1 controls
| Code | Title |
|---|---|
| 7.5 | Threat assessment |
Resource Management
1 controls
| Code | Title |
|---|---|
| 6.4 | Logging and Monitoring |
Your Compliance Coverage
If you comply with ISO 13485, you already cover:
NIST SP 800-66
45%
13 controls mapped
Compare →MDS2 (Medical Device)
45%
13 controls mapped
Compare →MARS-E
45%
13 controls mapped
Compare →+ 266 more: ISO 27799 (45%), NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements (41%)
See all 269 mapped frameworks ↓Maps to 269 other frameworks
29 total controls
NIST SP 800-66
13 source controls mapped|4 target controls covered
45%
MDS2 (Medical Device)
13 source controls mapped|5 target controls covered
45%
MARS-E
13 source controls mapped|7 target controls covered
45%
ISO 27799
13 source controls mapped|12 target controls covered
45%
NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements
12 source controls mapped|13 target controls covered
41%
NIST Privacy Framework
12 source controls mapped|5 target controls covered
41%
AWWA Cybersecurity Guidance for the Water Sector (American Water Works Association)
12 source controls mapped|8 target controls covered
41%
Oman National Cybersecurity Framework
11 source controls mapped|3 target controls covered
38%
FTC GLBA Safeguards Rule (16 CFR Part 314)
11 source controls mapped|2 target controls covered
38%
CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0
11 source controls mapped|8 target controls covered
38%
TISAX - Trusted Information Security Assessment Exchange
11 source controls mapped|6 target controls covered
38%
US Consumer Product Safety Commission (CPSC) - Connected Product Safety
10 source controls mapped|5 target controls covered
34%
PAS 1192-5:2015 - Security-Minded Approach to BIM and Digital Built Environments
10 source controls mapped|2 target controls covered
34%
NIST SP 800-82 Revision 3: Guide to Industrial Control Systems (ICS) Security
10 source controls mapped|4 target controls covered
34%
NIST SP 800-53 Rev 5
10 source controls mapped|20 target controls covered
34%
NIST SP 800-146
9 source controls mapped|3 target controls covered
31%
NIST SP 800-145
9 source controls mapped|3 target controls covered
31%
NIST SP 800-144
9 source controls mapped|4 target controls covered
31%
NAIC Insurance Data Security Model Law (MDL-668)
9 source controls mapped|3 target controls covered
31%
MTCS (Singapore)
9 source controls mapped|5 target controls covered
31%
BSI IT-Grundschutz
9 source controls mapped|11 target controls covered
31%
ISO 27018
9 source controls mapped|8 target controls covered
31%
ASD Strategies to Mitigate Cyber Security Incidents
9 source controls mapped|6 target controls covered
31%
South Korea ISMS-P
9 source controls mapped|7 target controls covered
31%
NIST SP 800-190
9 source controls mapped|7 target controls covered
31%
ISO 27017
9 source controls mapped|7 target controls covered
31%
Virginia CDPA
9 source controls mapped|2 target controls covered
31%
Vietnam PDPD
9 source controls mapped|2 target controls covered
31%
Uruguay DPL
9 source controls mapped|3 target controls covered
31%
Turkey KVKK
9 source controls mapped|2 target controls covered
31%
Texas Data Privacy Act
9 source controls mapped|2 target controls covered
31%
Taiwan PDPA
9 source controls mapped|2 target controls covered
31%
Qatar DPL
9 source controls mapped|2 target controls covered
31%
Privacy Act 2020
9 source controls mapped|3 target controls covered
31%
POPIA
9 source controls mapped|3 target controls covered
31%
Personal Data Act (personopplysningsloven)
9 source controls mapped|3 target controls covered
31%
PDPA Thailand
9 source controls mapped|3 target controls covered
31%
PDPA Singapore
9 source controls mapped|3 target controls covered
31%
Oregon Consumer Privacy Act
9 source controls mapped|3 target controls covered
31%
NIST SP 800-122
9 source controls mapped|2 target controls covered
31%
Nigeria Data Protection Regulation (NDPR)
9 source controls mapped|2 target controls covered
31%
Nigeria Data Protection Act 2023 (NDPA)
9 source controls mapped|5 target controls covered
31%
Nebraska Data Privacy Act
9 source controls mapped|5 target controls covered
31%
New Jersey Data Privacy Act
9 source controls mapped|3 target controls covered
31%
New Hampshire Data Privacy Act
9 source controls mapped|3 target controls covered
31%
Montana Consumer Data Privacy Act
9 source controls mapped|3 target controls covered
31%
Minnesota Consumer Data Privacy Act
9 source controls mapped|3 target controls covered
31%
Mexico LFPDPPP
9 source controls mapped|4 target controls covered
31%
Mauritius DPA
9 source controls mapped|4 target controls covered
31%
Maryland Online Data Privacy Act of 2024
9 source controls mapped|3 target controls covered
31%
Malaysia PDPA 2010
9 source controls mapped|3 target controls covered
31%
Liechtenstein DPA
9 source controls mapped|2 target controls covered
31%
LGPD
9 source controls mapped|2 target controls covered
31%
Kentucky Consumer Data Protection Act
9 source controls mapped|4 target controls covered
31%
Jamaica Data Protection Act 2020
9 source controls mapped|4 target controls covered
31%
Federal Decree-Law No. 45 of 2021 on the Protection of Personal Data (UAE PDPL)
9 source controls mapped|4 target controls covered
31%
Bahrain PDPL
9 source controls mapped|4 target controls covered
31%
Singapore Government Instruction Manual on ICT&SS Management (IM8)
9 source controls mapped|5 target controls covered
31%
Switzerland New Federal Act on Data Protection (nFADP/nDSG, 2023)
9 source controls mapped|7 target controls covered
31%
ISO/IEC 27011:2024
9 source controls mapped|7 target controls covered
31%
SOC for Cybersecurity - Cybersecurity Risk Management Examination
9 source controls mapped|3 target controls covered
31%
Saudi Arabia PDPL
9 source controls mapped|4 target controls covered
31%
ISO/IEC 27400:2022
8 source controls mapped|4 target controls covered
28%
SLSA
8 source controls mapped|2 target controls covered
28%
Sigstore - Software Artifact Signing and Verification
8 source controls mapped|4 target controls covered
28%
SIG (Shared Assessments)
8 source controls mapped|3 target controls covered
28%
PTES
8 source controls mapped|2 target controls covered
28%
OWASP SAMM
8 source controls mapped|2 target controls covered
28%
OWASP MASVS
8 source controls mapped|4 target controls covered
28%
OpenSSF Scorecard
8 source controls mapped|3 target controls covered
28%
O-RAN WG11 Security Specification
8 source controls mapped|3 target controls covered
28%
NIST SP 800-92
8 source controls mapped|3 target controls covered
28%
NIST SP 800-88
8 source controls mapped|3 target controls covered
28%
NIST SP 800-63-4
8 source controls mapped|3 target controls covered
28%
NIST SP 800-61
8 source controls mapped|3 target controls covered
28%
NIST SP 800-137
8 source controls mapped|3 target controls covered
28%
NIST SP 800-123
8 source controls mapped|3 target controls covered
28%
NIST SP 800-115 (Technical Guide to Information Security Testing and Assessment)
8 source controls mapped|2 target controls covered
28%
MITRE ATT&CK
8 source controls mapped|4 target controls covered
28%
ISO 27043
8 source controls mapped|9 target controls covered
28%
MARS-E - Minimum Acceptable Risk Standards for Exchanges
8 source controls mapped|2 target controls covered
28%
ISO/SAE 21434
8 source controls mapped|9 target controls covered
28%
Peru DPL
8 source controls mapped|2 target controls covered
28%
US ITAR and EAR - Export Control and Data Security
8 source controls mapped|3 target controls covered
28%
TSA Pipeline Cybersecurity Directives
7 source controls mapped|2 target controls covered
24%
Secure by Design: A Guide for Manufacturers (CISA)
7 source controls mapped|3 target controls covered
24%
NIST SP 800-124 Revision 2 - Guidelines for Managing the Security of Mobile Devices
7 source controls mapped|4 target controls covered
24%
South Korea PIPA
7 source controls mapped|2 target controls covered
24%
ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
6 source controls mapped|7 target controls covered
21%
Florida Digital Bill of Rights (FDBR)
6 source controls mapped|5 target controls covered
21%
NIS2 Directive Implementing Acts
6 source controls mapped|2 target controls covered
21%
IEC 62351 - Power Systems Communication Security
6 source controls mapped|3 target controls covered
21%
ISO/IEC 27010:2015
6 source controls mapped|4 target controls covered
21%
ITU-T X.805 - Security Architecture for End-to-End Communications
5 source controls mapped|2 target controls covered
17%
DAMA-DMBOK2 - Data Management Body of Knowledge (2nd Edition)
5 source controls mapped|2 target controls covered
17%
UK Telecommunications (Security) Act 2021
5 source controls mapped|1 target controls covered
17%
3GPP 5G Security Architecture (TS 33.501)
5 source controls mapped|5 target controls covered
17%
UK Gambling Commission - Cyber Resilience Requirements
5 source controls mapped|1 target controls covered
17%
APPI
5 source controls mapped|2 target controls covered
17%
FFIEC Cybersecurity Assessment Tool (CAT)
5 source controls mapped|5 target controls covered
17%
Annex 11 to EU GMP - Computerised Systems
5 source controls mapped|3 target controls covered
17%
ISO 28001:2007 Supply Chain Security Management
5 source controls mapped|3 target controls covered
17%
ISO 20000-1
5 source controls mapped|2 target controls covered
17%
FBI CJIS Security Policy
5 source controls mapped|5 target controls covered
17%
ISO 26000:2010
4 source controls mapped|1 target controls covered
14%
W3C Verifiable Credentials (VC) Data Model 2.0
4 source controls mapped|2 target controls covered
14%
TEFCA - Trusted Exchange Framework and Common Agreement
4 source controls mapped|2 target controls covered
14%
FIDO2 / WebAuthn
4 source controls mapped|2 target controls covered
14%
ISO/IEC 29115:2023 - Entity Authentication Assurance Framework
4 source controls mapped|4 target controls covered
14%
ISO/IEC 23837 - Security Requirements for Quantum Key Distribution
4 source controls mapped|3 target controls covered
14%
UK Open Banking Standard
4 source controls mapped|4 target controls covered
14%
NIST Cybersecurity Framework 2.0
4 source controls mapped|5 target controls covered
14%
SSAE 18 - Attestation Standards (SOC Reporting)
4 source controls mapped|5 target controls covered
14%
ISO 19011
4 source controls mapped|4 target controls covered
14%
API 1164
4 source controls mapped|4 target controls covered
14%
ICAO Annex 17 - Aviation Security (AVSEC)
4 source controls mapped|2 target controls covered
14%
IATA Operational Safety Audit (IOSA) Standards Manual
4 source controls mapped|1 target controls covered
14%
IAEA Nuclear Security Series - Computer Security at Nuclear Facilities (NSS-17-T Rev 1)
4 source controls mapped|2 target controls covered
14%
IEC 62443
4 source controls mapped|4 target controls covered
14%
ISO 27019
4 source controls mapped|4 target controls covered
14%
NIST SP 1800-32
4 source controls mapped|4 target controls covered
14%
UK Security and Emergency Measures Direction (SEMD) - Water Industry
4 source controls mapped|2 target controls covered
14%
New Zealand Information Security Manual (NZISM)
4 source controls mapped|2 target controls covered
14%
UNICEF Policy Guidance on AI for Children (2021)
4 source controls mapped|1 target controls covered
14%
UNESCO Recommendation on the Ethics of AI
4 source controls mapped|3 target controls covered
14%
UK GDPR (UK General Data Protection Regulation)
4 source controls mapped|2 target controls covered
14%
UK AI Regulation Framework
4 source controls mapped|2 target controls covered
14%
OECD AI Principles
4 source controls mapped|2 target controls covered
14%
NRF Cybersecurity and Data Privacy Framework (National Retail Federation)
4 source controls mapped|2 target controls covered
14%
Japan AI Guidelines
4 source controls mapped|2 target controls covered
14%
Barbados Data Protection Act 2019
4 source controls mapped|3 target controls covered
14%
GDPR
4 source controls mapped|3 target controls covered
14%
ISO/IEC 23894:2023
4 source controls mapped|4 target controls covered
14%
UK Age Appropriate Design Code (Children's Code)
4 source controls mapped|2 target controls covered
14%
Uganda Data Protection and Privacy Act (2019)
4 source controls mapped|4 target controls covered
14%
PIC/S Guide to Good Manufacturing Practice for Medicinal Products
3 source controls mapped|3 target controls covered
10%
SQF Code Edition 9 - Safe Quality Food
3 source controls mapped|4 target controls covered
10%
Regional Comprehensive Economic Partnership (RCEP) - E-Commerce Chapter
3 source controls mapped|2 target controls covered
10%
OWASP Top 10 for LLM Applications 2025
3 source controls mapped|4 target controls covered
10%
AML/CTF Act 2006 (Australia)
3 source controls mapped|2 target controls covered
10%
Canada ITSG-33 - IT Security Risk Management
3 source controls mapped|1 target controls covered
10%
SOC 2
3 source controls mapped|2 target controls covered
10%
ITIL 4
3 source controls mapped|1 target controls covered
10%
Nigeria Open Banking Regulatory Framework (CBN, 2023)
3 source controls mapped|2 target controls covered
10%
ISO 22739:2024 - Blockchain and Distributed Ledger Technologies Vocabulary
3 source controls mapped|4 target controls covered
10%
ISO 27005
3 source controls mapped|4 target controls covered
10%
Authorised Economic Operator (AEO) Programmes - Global Standards
3 source controls mapped|3 target controls covered
10%
Security of Critical Infrastructure Act 2018 (SOCI)
3 source controls mapped|3 target controls covered
10%
Trinidad and Tobago Data Protection Act 2011
3 source controls mapped|3 target controls covered
10%
Tanzania Personal Data Protection Act (Draft)
3 source controls mapped|1 target controls covered
10%
Student Privacy Pledge 2020
3 source controls mapped|1 target controls covered
10%
Paraguay Law on Protection of Personal Data (Law No. 6534/2020)
3 source controls mapped|1 target controls covered
10%
Nevada Gaming Control Board Cybersecurity Requirements
3 source controls mapped|1 target controls covered
10%
Jordan Draft Personal Data Protection Law (2022)
3 source controls mapped|2 target controls covered
10%
Austria Data Protection Act (Datenschutzgesetz, DSG, amended 2018)
3 source controls mapped|3 target controls covered
10%
Azerbaijan Law on Personal Data (2010)
3 source controls mapped|2 target controls covered
10%
Albania Law on Protection of Personal Data (Law No. 9887, 2008, amended 2014)
3 source controls mapped|1 target controls covered
10%
UK Defence Standard 05-138 - Cyber Security for Defence Suppliers
3 source controls mapped|1 target controls covered
10%
South Korea Korea Internet Self-Governance Organisation (KISO) Code of Ethics
3 source controls mapped|1 target controls covered
10%
Sweden Data Protection Act (Dataskyddslag, 2018:218)
3 source controls mapped|2 target controls covered
10%
Telecommunications Sector Security Reforms (TSSR)
3 source controls mapped|1 target controls covered
10%
ISO/IEC 25012:2008 - Data Quality Model
2 source controls mapped|1 target controls covered
7%
USMCA Chapter 19 - Digital Trade (United States-Mexico-Canada Agreement)
2 source controls mapped|1 target controls covered
7%
WCAG 2.2
2 source controls mapped|1 target controls covered
7%
US Maritime Transportation Security Act (MTSA) and USCG Cybersecurity Requirements
2 source controls mapped|1 target controls covered
7%
Armenia Law on Protection of Personal Data (2015)
2 source controls mapped|1 target controls covered
7%
Illinois Biometric Information Privacy Act (BIPA)
2 source controls mapped|2 target controls covered
7%
Bank Secrecy Act / Anti-Money Laundering (BSA/AML)
2 source controls mapped|1 target controls covered
7%
PSD2 SCA
2 source controls mapped|1 target controls covered
7%
OSFI B-13
2 source controls mapped|1 target controls covered
7%
Open Banking Security
2 source controls mapped|1 target controls covered
7%
NIST Post-Quantum Cryptography Standards (FIPS 203, 204, 205)
2 source controls mapped|3 target controls covered
7%
NATO STANAG 4774 (Confidentiality Metadata Labels) and STANAG 4778 (Metadata Binding)
2 source controls mapped|1 target controls covered
7%
Monetary Authority of Singapore Technology Risk Management Guidelines
2 source controls mapped|1 target controls covered
7%
ISO 31000:2018
2 source controls mapped|2 target controls covered
7%
AS9100D:2016 - Quality Management Systems for Aviation, Space, and Defence
2 source controls mapped|1 target controls covered
7%
FFIEC IT Examination Handbook
2 source controls mapped|1 target controls covered
7%
NSA Guidance for Transition to Quantum-Resistant Cryptography
2 source controls mapped|3 target controls covered
7%
PCI SSF
2 source controls mapped|1 target controls covered
7%
PCI P2PE
2 source controls mapped|1 target controls covered
7%
PCI PIN Security
2 source controls mapped|1 target controls covered
7%
NRC 10 CFR 73.54 - Nuclear Facility Cybersecurity
2 source controls mapped|1 target controls covered
7%
ICH E6(R3) - Good Clinical Practice
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%
GLOBALG.A.P. Integrated Farm Assurance (IFA) Standard v6
1 source controls mapped|2 target controls covered
3%
FSSC 22000 - Food Safety System Certification
1 source controls mapped|1 target controls covered
3%
FDA Quality Management System Regulation (QMSR)
1 source controls mapped|2 target controls covered
3%
21 CFR Part 211 - Current Good Manufacturing Practice
1 source controls mapped|3 target controls covered
3%
PCI DSS 4.0
1 source controls mapped|2 target controls covered
3%
BRCGS Global Standard for Food Safety Issue 9
1 source controls mapped|3 target controls covered
3%
21 CFR Part 58 - Good Laboratory Practice (GLP)
1 source controls mapped|1 target controls covered
3%
Singapore AI Governance Framework
1 source controls mapped|1 target controls covered
3%
ISO/IEC 17025:2017 - General Requirements for Testing and Calibration
1 source controls mapped|1 target controls covered
3%
IEC 62304:2015 Medical Device Software Lifecycle Processes
1 source controls mapped|1 target controls covered
3%
Papua New Guinea National Cybersecurity Policy & Cybercrime Act (2016)
1 source controls mapped|1 target controls covered
3%
Lebanon Electronic Transactions and Personal Data Protection Law (Law No. 81/2018)
1 source controls mapped|1 target controls covered
3%
IATF 16949:2016 - Quality Management System for Automotive Production
1 source controls mapped|3 target controls covered
3%
AS9100D - Aerospace Quality Management System
1 source controls mapped|2 target controls covered
3%
UNECE WP.29 R155
1 source controls mapped|1 target controls covered
3%
ISO 27018:2019
1 source controls mapped|1 target controls covered
3%
ISO 27701:2019
1 source controls mapped|1 target controls covered
3%
ISO 27017:2015
1 source controls mapped|1 target controls covered
3%
Vermont Artificial Intelligence and Consumer Data Act (AICDA)
1 source controls mapped|1 target controls covered
3%
US EPA Safe Drinking Water Act (SDWA) - Cybersecurity Requirements
1 source controls mapped|1 target controls covered
3%
Regulation on the European Health Data Space (EHDS)
1 source controls mapped|1 target controls covered
3%
OWASP Top 10:2025
1 source controls mapped|2 target controls covered
3%
OWASP DevSecOps Maturity Model (DSOMM)
1 source controls mapped|1 target controls covered
3%
OWASP ASVS
1 source controls mapped|1 target controls covered
3%
OWASP API Security Top 10 - 2023
1 source controls mapped|1 target controls covered
3%
MITRE D3FEND
1 source controls mapped|1 target controls covered
3%
ISMAP (Japan)
1 source controls mapped|1 target controls covered
3%
IACS Unified Requirements E26/E27 - Cyber Resilience of Ships and On-Board Systems
1 source controls mapped|1 target controls covered
3%
HL7 FHIR Security Framework
1 source controls mapped|1 target controls covered
3%
GLI-33 - Gaming Laboratories International Event Wagering Systems
1 source controls mapped|1 target controls covered
3%
Ghana Cybersecurity Act
1 source controls mapped|1 target controls covered
3%
FISMA
1 source controls mapped|1 target controls covered
3%
FedRAMP Rev 5
1 source controls mapped|1 target controls covered
3%
FDA 21 CFR Part 11
1 source controls mapped|1 target controls covered
3%
FCC Customer Proprietary Network Information (CPNI) and Data Breach Rules (47 CFR 64.2001-2011)
1 source controls mapped|1 target controls covered
3%
Belgium CyberFundamentals
1 source controls mapped|1 target controls covered
3%
ISO 19011:2018
1 source controls mapped|1 target controls covered
3%
Australia NHMRC National Statement on Ethical Conduct in Human Research
1 source controls mapped|1 target controls covered
3%
ISO/IEC 27007:2020
1 source controls mapped|1 target controls covered
3%
ISO 14064 - Greenhouse Gas Accounting and Verification (Parts 1-3)
1 source controls mapped|1 target controls covered
3%
Aged Care Adjacent Schemes (Australia)
1 source controls mapped|1 target controls covered
3%
UK FCA/PRA Operational Resilience Framework
1 source controls mapped|1 target controls covered
3%
SEC Climate Disclosure Rule
1 source controls mapped|1 target controls covered
3%
Own Risk and Solvency Assessment (ORSA) - NAIC Model Act
1 source controls mapped|2 target controls covered
3%
OECD Guidelines for Multinational Enterprises on Responsible Business Conduct (2023 Update)
1 source controls mapped|1 target controls covered
3%
NIST SP 800-39
1 source controls mapped|1 target controls covered
3%
NIST SP 800-37
1 source controls mapped|2 target controls covered
3%
NIST SP 800-30
1 source controls mapped|3 target controls covered
3%
NERC CIP
1 source controls mapped|1 target controls covered
3%
Lloyd's of London Cyber Insurance Requirements and Underwriting Standards
1 source controls mapped|2 target controls covered
3%
German Supply Chain Due Diligence Act (LkSG)
1 source controls mapped|2 target controls covered
3%
French Sapin II Law (Law No. 2016-1691)
1 source controls mapped|2 target controls covered
3%
APRA CPS 230 Operational Risk Management
1 source controls mapped|1 target controls covered
3%
UAE Virtual Asset Regulatory Authority (VARA) Regulations
1 source controls mapped|2 target controls covered
3%
EASA Part-IS - Information Security in Aviation
1 source controls mapped|2 target controls covered
3%
ISO 26262:2018 - Functional Safety for Road Vehicles
1 source controls mapped|1 target controls covered
3%
ISO/IEC 29134:2023
1 source controls mapped|1 target controls covered
3%
ISO/IEC 27557:2022 - Organisational Privacy Risk Management
1 source controls mapped|2 target controls covered
3%
ASIS SPC.1-2009 - Organizational Resilience Standard
1 source controls mapped|1 target controls covered
3%
ISO/IEC 29147:2018
1 source controls mapped|1 target controls covered
3%
ISO/IEC 27031:2011
1 source controls mapped|1 target controls covered
3%
ISO 22313:2020 - Guidance on Business Continuity Management Systems
1 source controls mapped|1 target controls covered
3%
Singapore Cybersecurity Act 2018
1 source controls mapped|1 target controls covered
3%
APRA SPS 220 Risk Management (Superannuation)
1 source controls mapped|1 target controls covered
3%
AICPA Privacy Management Framework (PMF)
1 source controls mapped|1 target controls covered
3%
Responsible Minerals Initiative (RMI) - Responsible Minerals Assurance Process
1 source controls mapped|3 target controls covered
3%
UK Modern Slavery Act 2015
1 source controls mapped|1 target controls covered
3%
Kuwait National Cybersecurity Framework
1 source controls mapped|1 target controls covered
3%
ISO 31000
1 source controls mapped|3 target controls covered
3%
ISO/IEC 27003:2017
1 source controls mapped|2 target controls covered
3%
NFPA 1600 - Standard on Continuity, Emergency, and Crisis Management
1 source controls mapped|1 target controls covered
3%
ISO 45001
1 source controls mapped|1 target controls covered
3%
FedRAMP High
1 source controls mapped|1 target controls covered
3%
NIST SP 800-53 Revision 5.1 HIGH
1 source controls mapped|1 target controls covered
3%
FedRAMP Moderate
1 source controls mapped|1 target controls covered
3%
NIST SP 800-53 Rev 5 MODERATE
1 source controls mapped|1 target controls covered
3%
NIST SP 800-53 Rev 5 LOW
1 source controls mapped|1 target controls covered
3%
SANS Incident Handler's Handbook and PICERL Methodology
1 source controls mapped|1 target controls covered
3%
ISO 22000
1 source controls mapped|1 target controls covered
3%
Space ISAC (Information Sharing and Analysis Center) - Threat Framework
1 source controls mapped|1 target controls covered
3%
NIST SP 800-171
1 source controls mapped|1 target controls covered
3%
ITAR - International Traffic in Arms Regulations
1 source controls mapped|2 target controls covered
3%
ISO 19650 - Organisation and Digitisation of Information about Buildings and Civil Engineering Works (BIM)
1 source controls mapped|1 target controls covered
3%
US Automated Commercial Environment (ACE) - CBP Trade Data Requirements
1 source controls mapped|1 target controls covered
3%
Samoa Telecommunications Act (2005) - Privacy & Data Protection
1 source controls mapped|2 target controls covered
3%
What is ISO 13485 and who does it apply to?
ISO 13485 is a compliance framework from International with 10 domains and 29 controls. Medical devices - Quality management systems It is used by organisations to establish and maintain compliance with industry standards and regulatory requirements.
What does ISO 13485 actually require?
ISO 13485 has 29 controls organised across 10 domains. The largest domains are ISO 13485: Administrative Safeguards (6 controls), ISO 13485: Patient Data Protection (5 controls), ISO 13485: Technical Safeguards (5 controls). Each control defines specific requirements that organisations must implement to achieve compliance.
If I already comply with another framework, how much of ISO 13485 do I already cover?
ISO 13485 maps to 269 other compliance frameworks. The top mapping partners are NIST SP 800-66 (45% coverage), MDS2 (Medical Device) (45% coverage), MARS-E (45% coverage). Use our comparison tool to explore control-level mappings between frameworks.
How do I implement ISO 13485?
Start your ISO 13485 compliance journey by running a self-assessment on our platform to identify your current compliance posture. Our AI advisory can answer specific questions about ISO 13485 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 29 controls and track your progress.
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