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MDS2 (Medical Device)
United States
v2019
8 domains
8 controls
Manufacturer Disclosure Statement for Medical Device Security
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 (8)
Audit Logging Integrity and Cybersecurity Risk - MDS2
1 controls
| Code | Title |
|---|---|
| MDS2-Audit-Logging-AUDT-Integrity-IGAU-Cybersecurity-Risk-CYBR-Monitoring | MDS2 Audit Controls + AUDT + Integrity + IGAU + Cybersecurity Risk + CYBR + Continuous Monitoring |
Authentication and Authorization - MDS2
1 controls
| Code | Title |
|---|---|
| MDS2-Person-Node-Authentication-Authorization-Auto-Logoff-AUTH-PAUT-NAUT | MDS2 Authentication + Authorization + Auto Logoff + PAUT + NAUT + AUTH + Identity Management |
Device Identification and Inventory - MDS2
1 controls
| Code | Title |
|---|---|
| MDS2-Device-Identification-Inventory-MGMT-Configuration-Asset-Management | MDS2 Device Identification + MGMT + Configuration + Asset Management + HDO Inventory |
Malware Detection System Hardening and Cybersecurity Upgrades - MDS2
1 controls
| Code | Title |
|---|---|
| MDS2-Malware-Detection-MLDP-System-Hardening-SAHD-Cybersecurity-Upgrades-CSUP-Patch-Management | MDS2 Malware Detection + MLDP + System Hardening + SAHD + Cybersecurity Upgrades + CSUP + Patch Management |
PHI Data Handling Storage and Transmission - MDS2
1 controls
| Code | Title |
|---|---|
| MDS2-PHI-Data-Handling-DATA-Storage-STCF-Transmission-TXCF-TXIG-Encryption-FIPS | MDS2 PHI Handling + DATA + STCF Storage + TXCF Transmission + TXIG Integrity + Encryption + FIPS |
Physical Security Workstation Disposal and Backup - MDS2
1 controls
| Code | Title |
|---|---|
| MDS2-Physical-Security-PLOK-Workstation-Disposal-Backup-DTBK-Disaster-Recovery | MDS2 Physical Security + PLOK + Workstation + Disposal + Backup + DTBK + Disaster Recovery |
Roadmap Third Party Security Guidance and Vulnerability Disclosure - MDS2
1 controls
| Code | Title |
|---|---|
| MDS2-Roadmap-Third-Party-RDMP-Security-Guidance-SGUD-SBOM-Vulnerability-Disclosure-Programme | MDS2 Roadmap + RDMP + Third Party + Security Guidance + SGUD + SBOM + Vulnerability Disclosure + Coordinated |
Scope and Authority - MDS2 Manufacturer Disclosure Statement
1 controls
| Code | Title |
|---|---|
| MDS2-Scope-NEMA-HN-1-2019-HIMSS-AAMI-Manufacturer-Disclosure-FDA-Section-524B-Procurement-Voluntary | MDS2 Scope + NEMA HN 1-2019 + HIMSS + AAMI + FDA Section 524B + Procurement + Voluntary Industry Standard |
Your Compliance Coverage
If you comply with MDS2 (Medical Device), you already cover:
NIST SP 800-171A - Assessing Security Requirements for Controlled Unclassified Information (CUI)
63%
5 controls mapped
Compare →ISO 28001:2007 Supply Chain Security Management
63%
5 controls mapped
Compare →NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements
63%
5 controls mapped
Compare →+ 166 more: OWASP DevSecOps Maturity Model (DSOMM) (63%), ISO/IEC 27011:2024 (63%)
See all 169 mapped frameworks ↓Maps to 169 other frameworks
8 total controls
NIST SP 800-171A - Assessing Security Requirements for Controlled Unclassified Information (CUI)
5 source controls mapped|15 target controls covered
63%
ISO 28001:2007 Supply Chain Security Management
5 source controls mapped|3 target controls covered
63%
NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements
5 source controls mapped|10 target controls covered
63%
OWASP DevSecOps Maturity Model (DSOMM)
5 source controls mapped|6 target controls covered
63%
ISO/IEC 27011:2024
5 source controls mapped|7 target controls covered
63%
UK Defence Standard 05-138 - Cyber Security for Defence Suppliers
5 source controls mapped|7 target controls covered
63%
CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0
5 source controls mapped|8 target controls covered
63%
FTC GLBA Safeguards Rule (16 CFR Part 314)
5 source controls mapped|2 target controls covered
63%
AWWA Cybersecurity Guidance for the Water Sector (American Water Works Association)
5 source controls mapped|8 target controls covered
63%
FFIEC Cybersecurity Assessment Tool (CAT)
5 source controls mapped|5 target controls covered
63%
UK ONR Cyber Security and Information Assurance (CSIA) for Nuclear Facilities
5 source controls mapped|4 target controls covered
63%
ISO 27001:2022
5 source controls mapped|10 target controls covered
63%
ISO 27799
5 source controls mapped|12 target controls covered
63%
ISO 13485
5 source controls mapped|13 target controls covered
63%
ASD Strategies to Mitigate Cyber Security Incidents
4 source controls mapped|6 target controls covered
50%
IATA Operational Safety Audit (IOSA) Standards Manual
4 source controls mapped|1 target controls covered
50%
MITRE D3FEND
4 source controls mapped|2 target controls covered
50%
OWASP MASVS
4 source controls mapped|7 target controls covered
50%
ISO/IEC 27010:2015
4 source controls mapped|4 target controls covered
50%
BSI IT-Grundschutz
4 source controls mapped|11 target controls covered
50%
Malaysia PDPA 2010
4 source controls mapped|3 target controls covered
50%
ISO 27043
4 source controls mapped|9 target controls covered
50%
Protective Security Policy Framework (PSPF) Release 2024
4 source controls mapped|6 target controls covered
50%
IEC 62351 - Power Systems Communication Security
4 source controls mapped|3 target controls covered
50%
South Korea PIPA
4 source controls mapped|2 target controls covered
50%
Singapore Government Instruction Manual on ICT&SS Management (IM8)
4 source controls mapped|5 target controls covered
50%
OWASP Top 10:2025
4 source controls mapped|8 target controls covered
50%
OWASP ASVS
4 source controls mapped|9 target controls covered
50%
Regulation (EU) 2019/1239 on the Maritime Single Window (MSW)
4 source controls mapped|2 target controls covered
50%
Turkey KVKK
4 source controls mapped|4 target controls covered
50%
Turkey Personal Data Protection Law (KVKK - Law No. 6698)
4 source controls mapped|3 target controls covered
50%
API 1164
4 source controls mapped|4 target controls covered
50%
Annex 11 to EU GMP - Computerised Systems
4 source controls mapped|3 target controls covered
50%
Switzerland FADP
4 source controls mapped|4 target controls covered
50%
APPI
4 source controls mapped|4 target controls covered
50%
ISO 27019
4 source controls mapped|4 target controls covered
50%
US Consumer Product Safety Commission (CPSC) - Connected Product Safety
4 source controls mapped|3 target controls covered
50%
ISO/SAE 21434
4 source controls mapped|9 target controls covered
50%
Spain ENS
4 source controls mapped|10 target controls covered
50%
Privacy Act 1988 (Australia)
4 source controls mapped|4 target controls covered
50%
IEC 62443
4 source controls mapped|4 target controls covered
50%
Bahrain PDPL
4 source controls mapped|4 target controls covered
50%
South Korea ISMS-P
4 source controls mapped|7 target controls covered
50%
Mauritius DPA
4 source controls mapped|4 target controls covered
50%
ICAO Annex 17 - Aviation Security (AVSEC)
4 source controls mapped|2 target controls covered
50%
Federal Decree-Law No. 45 of 2021 on the Protection of Personal Data (UAE PDPL)
4 source controls mapped|4 target controls covered
50%
IAEA Nuclear Security Series - Computer Security at Nuclear Facilities (NSS-17-T Rev 1)
4 source controls mapped|2 target controls covered
50%
MARS-E - Minimum Acceptable Risk Standards for Exchanges
4 source controls mapped|2 target controls covered
50%
TISAX - Trusted Information Security Assessment Exchange
4 source controls mapped|5 target controls covered
50%
Telecommunications Sector Security Reforms (TSSR)
4 source controls mapped|5 target controls covered
50%
FBI CJIS Security Policy
3 source controls mapped|5 target controls covered
38%
NIS2 Directive Implementing Acts
3 source controls mapped|1 target controls covered
38%
ITU-T X.805 - Security Architecture for End-to-End Communications
3 source controls mapped|2 target controls covered
38%
ITIL 4
3 source controls mapped|1 target controls covered
38%
DAMA-DMBOK2 - Data Management Body of Knowledge (2nd Edition)
3 source controls mapped|2 target controls covered
38%
UK Security and Emergency Measures Direction (SEMD) - Water Industry
3 source controls mapped|1 target controls covered
38%
Canada ITSG-33 - IT Security Risk Management
3 source controls mapped|1 target controls covered
38%
OWASP API Security Top 10 - 2023
3 source controls mapped|5 target controls covered
38%
ISO 20000-1
3 source controls mapped|2 target controls covered
38%
US EPA Safe Drinking Water Act (SDWA) - Cybersecurity Requirements
3 source controls mapped|1 target controls covered
38%
NATO AQAP 2110 - Quality Assurance Requirements for Design, Development, and Production
3 source controls mapped|1 target controls covered
38%
Aged Care Quality Standards (Australia)
3 source controls mapped|4 target controls covered
38%
Regulation on the European Health Data Space (EHDS)
3 source controls mapped|4 target controls covered
38%
Azure Security Benchmark
3 source controls mapped|7 target controls covered
38%
ISO/IEC 17025:2017 - General Requirements for Testing and Calibration Laboratories
3 source controls mapped|3 target controls covered
38%
ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
3 source controls mapped|8 target controls covered
38%
ISO 27018
3 source controls mapped|8 target controls covered
38%
ISO 27017
3 source controls mapped|7 target controls covered
38%
Vermont Artificial Intelligence and Consumer Data Act (AICDA)
3 source controls mapped|6 target controls covered
38%
ICH Q10 - Pharmaceutical Quality System
3 source controls mapped|3 target controls covered
38%
Florida Digital Bill of Rights (FDBR)
3 source controls mapped|3 target controls covered
38%
ISO/IEC 27400:2022
3 source controls mapped|4 target controls covered
38%
AWS Well-Architected Security Pillar
3 source controls mapped|7 target controls covered
38%
Russia Federal Law on Personal Data (152-FZ)
3 source controls mapped|2 target controls covered
38%
NIST SP 800-124 Revision 2 - Guidelines for Managing the Security of Mobile Devices
3 source controls mapped|4 target controls covered
38%
Rhode Island Data Transparency and Privacy Protection Act (RIDTPPA)
3 source controls mapped|1 target controls covered
38%
Wisconsin Data Privacy Act (SB 670)
3 source controls mapped|3 target controls covered
38%
TEFCA - Trusted Exchange Framework and Common Agreement
3 source controls mapped|4 target controls covered
38%
COSO Internal Control - Integrated Framework (2013)
3 source controls mapped|2 target controls covered
38%
IEC 60601-1 - Medical Electrical Equipment Safety
3 source controls mapped|1 target controls covered
38%
FDA Quality Management System Regulation (QMSR)
3 source controls mapped|1 target controls covered
38%
Tennessee Information Protection Act (TIPA)
3 source controls mapped|2 target controls covered
38%
WELL Building Standard v2 (International WELL Building Institute)
3 source controls mapped|1 target controls covered
38%
Spain Organic Law 3/2018 on Data Protection and Digital Rights (LOPDGDD)
2 source controls mapped|1 target controls covered
25%
ISO/IEC 23894:2023
2 source controls mapped|4 target controls covered
25%
Senegal Law on Personal Data Protection (Law No. 2008-12)
2 source controls mapped|2 target controls covered
25%
Tunisia Organic Law on Personal Data Protection (Law No. 2004-63)
2 source controls mapped|3 target controls covered
25%
AS9100D:2016 - Quality Management Systems for Aviation, Space, and Defence
2 source controls mapped|2 target controls covered
25%
ISO 27005
2 source controls mapped|4 target controls covered
25%
Serbia Law on Personal Data Protection (2018)
2 source controls mapped|2 target controls covered
25%
ISO/IEC 23837 - Security Requirements for Quantum Key Distribution
2 source controls mapped|4 target controls covered
25%
Switzerland New Federal Act on Data Protection (nFADP/nDSG, 2023)
2 source controls mapped|3 target controls covered
25%
Austria Data Protection Act (Datenschutzgesetz, DSG, amended 2018)
2 source controls mapped|3 target controls covered
25%
Saudi PDPL
2 source controls mapped|4 target controls covered
25%
ISO 19011
2 source controls mapped|4 target controls covered
25%
ISO/IEC 29115:2023 - Entity Authentication Assurance Framework
2 source controls mapped|4 target controls covered
25%
Pakistan Personal Data Protection Bill 2023
2 source controls mapped|2 target controls covered
25%
ISO 26000:2010
2 source controls mapped|1 target controls covered
25%
Rwanda Law No. 058/2021 Relating to the Protection of Personal Data
2 source controls mapped|2 target controls covered
25%
GDPR
2 source controls mapped|3 target controls covered
25%
Albania Law on Protection of Personal Data (Law No. 9887, 2008, amended 2014)
2 source controls mapped|2 target controls covered
25%
Vietnam Law on Cybersecurity (No. 24/2018/QH14)
2 source controls mapped|2 target controls covered
25%
ISO/IEC 27557:2022 - Organisational Privacy Risk Management
2 source controls mapped|3 target controls covered
25%
Poland Act on Personal Data Protection (Ustawa o ochronie danych osobowych, 2018)
2 source controls mapped|1 target controls covered
25%
Barbados Data Protection Act 2019
2 source controls mapped|3 target controls covered
25%
OWASP Top 10 for LLM Applications 2025
2 source controls mapped|4 target controls covered
25%
South Korea Korea Internet Self-Governance Organisation (KISO) Code of Ethics
2 source controls mapped|1 target controls covered
25%
Panama Law on Personal Data Protection (Law No. 81 of 2019)
2 source controls mapped|2 target controls covered
25%
Uzbekistan Law on Personal Data (No. ZRU-547)
2 source controls mapped|1 target controls covered
25%
Azerbaijan Law on Personal Data (2010)
2 source controls mapped|2 target controls covered
25%
Portugal Law No. 58/2019 - Data Protection Implementation Act
2 source controls mapped|2 target controls covered
25%
Peru Personal Data Protection Law (Law No. 29733)
2 source controls mapped|1 target controls covered
25%
Uruguay Personal Data Protection Act (Law No. 18.331)
2 source controls mapped|1 target controls covered
25%
Oman Personal Data Protection Law (Royal Decree 6/2022)
2 source controls mapped|1 target controls covered
25%
Qatar Personal Data Privacy Protection Law (Law No. 13 of 2016)
2 source controls mapped|1 target controls covered
25%
FIDO2 / WebAuthn
2 source controls mapped|1 target controls covered
25%
AML/CTF Act 2006 (Australia)
2 source controls mapped|2 target controls covered
25%
Space ISAC (Information Sharing and Analysis Center) - Threat Framework
1 source controls mapped|1 target controls covered
13%
NIST Special Publication 800-34 Revision 1, Contingency Planning Guide for Federal Information Systems
1 source controls mapped|1 target controls covered
13%
NIST Post-Quantum Cryptography Standards (FIPS 203, 204, 205)
1 source controls mapped|4 target controls covered
13%
Monetary Authority of Singapore Technology Risk Management Guidelines
1 source controls mapped|1 target controls covered
13%
MiFID II / MiFIR
1 source controls mapped|1 target controls covered
13%
ISO 22739:2024 - Blockchain and Distributed Ledger Technologies Vocabulary
1 source controls mapped|4 target controls covered
13%
ISO/IEC 27006:2024
1 source controls mapped|1 target controls covered
13%
US Automated Commercial Environment (ACE) - CBP Trade Data Requirements
1 source controls mapped|1 target controls covered
13%
ISO 31000:2018
1 source controls mapped|2 target controls covered
13%
APRA CPS 234
1 source controls mapped|1 target controls covered
13%
ISO 19650 - Organisation and Digitisation of Information about Buildings and Civil Engineering Works (BIM)
1 source controls mapped|1 target controls covered
13%
FFIEC IT Examination Handbook
1 source controls mapped|1 target controls covered
13%
NIST Privacy Framework
1 source controls mapped|1 target controls covered
13%
Nevada Gaming Control Board Cybersecurity Requirements
1 source controls mapped|3 target controls covered
13%
ISO 31000
1 source controls mapped|3 target controls covered
13%
SQF Code Edition 9 - Safe Quality Food
1 source controls mapped|2 target controls covered
13%
NIST AI Risk Management Framework (AI RMF 1.0)
1 source controls mapped|2 target controls covered
13%
French Sapin II Law (Law No. 2016-1691)
1 source controls mapped|2 target controls covered
13%
ISO 22000
1 source controls mapped|1 target controls covered
13%
ISO/IEC 29134:2023
1 source controls mapped|3 target controls covered
13%
ISO/IEC 27014:2020
1 source controls mapped|2 target controls covered
13%
EASA Part-IS - Information Security in Aviation
1 source controls mapped|2 target controls covered
13%
Union Customs Code (UCC) - Regulation (EU) No 952/2013
1 source controls mapped|2 target controls covered
13%
AS9100D - Aerospace Quality Management System
1 source controls mapped|2 target controls covered
13%
ISO/IEC 27003:2017
1 source controls mapped|2 target controls covered
13%
ISO/IEC 27031:2011
1 source controls mapped|1 target controls covered
13%
UAE Virtual Asset Regulatory Authority (VARA) Regulations
1 source controls mapped|2 target controls covered
13%
PCAOB AS 2201 - Audit of Internal Control Over Financial Reporting (ICFR)
1 source controls mapped|2 target controls covered
13%
ASIS SPC.1-2009 - Organizational Resilience Standard
1 source controls mapped|1 target controls covered
13%
US Gramm-Leach-Bliley Act (GLBA) - Higher Education Safeguards Rule
1 source controls mapped|2 target controls covered
13%
ISO 26262:2018 - Functional Safety for Road Vehicles
1 source controls mapped|1 target controls covered
13%
ISO/IEC 25012:2008 - Data Quality Model
1 source controls mapped|1 target controls covered
13%
Authorised Economic Operator (AEO) Programmes - Global Standards
1 source controls mapped|1 target controls covered
13%
WCO Authorised Economic Operator (AEO) Framework
1 source controls mapped|1 target controls covered
13%
ISO 45001
1 source controls mapped|1 target controls covered
13%
Papua New Guinea National Cybersecurity Policy & Cybercrime Act (2016)
1 source controls mapped|2 target controls covered
13%
RBI Cybersecurity Framework for Banks
1 source controls mapped|2 target controls covered
13%
NIST SP 800-171
1 source controls mapped|1 target controls covered
13%
ISO 41001:2018 - Facility Management Systems
1 source controls mapped|1 target controls covered
13%
ISO 39001:2012 - Road Traffic Safety Management
1 source controls mapped|1 target controls covered
13%
ISO 50001:2018 - Energy Management Systems
1 source controls mapped|1 target controls covered
13%
ISO 22313:2020 - Guidance on Business Continuity Management Systems
1 source controls mapped|1 target controls covered
13%
APRA CPS 230 Operational Risk Management
1 source controls mapped|1 target controls covered
13%
ISO/IEC 29147:2018
1 source controls mapped|1 target controls covered
13%
South Korea Cloud Security Assurance Program (CSAP)
1 source controls mapped|1 target controls covered
13%
SWIFT CSCF
1 source controls mapped|1 target controls covered
13%
SWIFT CSCF v2024
1 source controls mapped|1 target controls covered
13%
Armenia Law on Protection of Personal Data (2015)
1 source controls mapped|1 target controls covered
13%
USMCA Chapter 19 - Digital Trade (United States-Mexico-Canada Agreement)
1 source controls mapped|1 target controls covered
13%
Illinois Biometric Information Privacy Act (BIPA)
1 source controls mapped|2 target controls covered
13%
US Maritime Transportation Security Act (MTSA) and USCG Cybersecurity Requirements
1 source controls mapped|1 target controls covered
13%
Bank Secrecy Act / Anti-Money Laundering (BSA/AML)
1 source controls mapped|1 target controls covered
13%
Frequently Asked Questions
What is MDS2 (Medical Device)?
MDS2 (Medical Device) is a compliance framework from United States with 8 domains and 8 controls. Manufacturer Disclosure Statement for Medical Device Security It is used by organisations to establish and maintain compliance with industry standards and regulatory requirements.
How many controls does MDS2 (Medical Device) have?
MDS2 (Medical Device) has 8 controls organised across 8 domains. The largest domains are Audit Logging Integrity and Cybersecurity Risk - MDS2 (1 controls), Authentication and Authorization - MDS2 (1 controls), Device Identification and Inventory - MDS2 (1 controls). Each control defines specific requirements that organisations must implement to achieve compliance.
What frameworks does MDS2 (Medical Device) map to?
MDS2 (Medical Device) maps to 169 other compliance frameworks. The top mapping partners are NIST SP 800-171A - Assessing Security Requirements for Controlled Unclassified Information (CUI) (63% coverage), ISO 28001:2007 Supply Chain Security Management (63% coverage), NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements (63% coverage). Use our comparison tool to explore control-level mappings between frameworks.
How do I get started with MDS2 (Medical Device) compliance?
Start your MDS2 (Medical Device) compliance journey by running a self-assessment on our platform to identify your current compliance posture. Our AI advisory can answer specific questions about MDS2 (Medical Device) 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 8 controls and track your progress.
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