MDS2 (Medical Device)
Manufacturer Disclosure Statement for Medical Device Security
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 (5)
MDS2 (Medical Device): Administrative Safeguards
Organizational security management (MDS2 (Medical Device))
| Code | Title |
|---|---|
| MDS2-06 | Security management process and risk analysis |
| MDS2-07 | Workforce security and clearance procedures |
| MDS2-08 | Information access management |
| MDS2-09 | Security awareness and training program |
| MDS2-10 | Contingency planning for ePHI |
| MDS2-11 | Business associate management |
MDS2 (Medical Device): Organizational Requirements
Policies, procedures, and documentation (MDS2 (Medical Device))
| Code | Title |
|---|---|
| MDS2-21 | Security and privacy policies |
| MDS2-22 | Documentation and record retention |
| MDS2-23 | Compliance evaluation and review |
| MDS2-24 | Incident reporting procedures |
MDS2 (Medical Device): Patient Data Protection
Safeguarding protected health information (MDS2 (Medical Device))
| Code | Title |
|---|---|
| MDS2-01 | ePHI access controls and authorization |
| MDS2-02 | ePHI encryption at rest and in transit |
| MDS2-03 | Minimum necessary standard enforcement |
| MDS2-04 | Patient data de-identification procedures |
| MDS2-05 | Audit trail for ePHI access |
MDS2 (Medical Device): Physical Safeguards
Physical security for systems with ePHI (MDS2 (Medical Device))
| Code | Title |
|---|---|
| MDS2-17 | Facility access controls |
| MDS2-18 | Workstation security and use policies |
| MDS2-19 | Device and media controls |
| MDS2-20 | Disposal and re-use procedures |
MDS2 (Medical Device): Technical Safeguards
Technical measures for ePHI protection (MDS2 (Medical Device))
| Code | Title |
|---|---|
| MDS2-12 | Unique user identification and authentication |
| MDS2-13 | Automatic logoff and session management |
| MDS2-14 | Audit controls and monitoring |
| MDS2-15 | Integrity controls for ePHI |
| MDS2-16 | Transmission security and encryption |
Maps to 557 other frameworks
Frequently Asked Questions
What is MDS2 (Medical Device)?
MDS2 (Medical Device) is a compliance framework from United States with 5 domains and 24 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 24 controls organised across 5 domains. The largest domains are MDS2 (Medical Device): Administrative Safeguards (6 controls), MDS2 (Medical Device): Patient Data Protection (5 controls), MDS2 (Medical Device): Technical Safeguards (5 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 557 other compliance frameworks. The top mapping partners are US Gramm-Leach-Bliley Act (GLBA) — Higher Education Safeguards Rule (46% coverage), NIST SP 800-171A Rev 3 — Assessing CUI Security Requirements (42% coverage), GLI-33 — Gaming Laboratories International Event Wagering Systems (42% 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 24 controls and track your progress.
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