MDS2 (Medical Device)
What is MDS2 (Medical Device)?
Manufacturer Disclosure Statement for Medical Device Security. It comprises 25 controls organised across 4 domains, and applies in the United States.
How MDS2 (Medical Device) maps to other frameworks
All 25 controls, each one mapped to the equivalent requirement in other standards, with the evidence that carries across and the mappings that were judged and rejected shown alongside. No account needed to look.
See the control mappings →The 4 domains MDS2 (Medical Device) groups its controls into
Frameworks that share controls with MDS2 (Medical Device)
Each of these has at least one control mapped to a control in MDS2 (Medical Device). The number is how many MDS2 (Medical Device) controls are shared, counted from the mapping graph.
OWASP DevSecOps Maturity Model (DSOMM)
5 shared controlsNIST SP 800-171A Rev 3 - Assessing CUI Security Requirements
5 shared controlsFTC GLBA Safeguards Rule (16 CFR Part 314)
5 shared controlsAWWA Cybersecurity Guidance for the Water Sector (American Water Works Association)
5 shared controlsFFIEC Cybersecurity Assessment Tool (CAT)
5 shared controlsISO 27799
5 shared controlsISO 13485
5 shared controlsASD Strategies to Mitigate Cyber Security Incidents
4 shared controlsWhere MDS2 (Medical Device) overlaps with the standards you already hold
Where to get trained on MDS2 (Medical Device)
One course in the catalogue covers MDS2 (Medical Device) directly. Each is self-paced, includes the downloadable toolkit and the implementation playbook, and carries a certificate of completion.
Training more than one person? Ten seats of any course is $1,490 on a single licence, against $199 a seat bought one at a time.
What an auditor will ask you for
All 8 MDS2 (Medical Device) controls, each with what it requires, the artefacts an auditor will ask you for, and where it commonly fails. Free to read, nothing to fill in.
Read the MDS2 (Medical Device) evidence request listWhat MDS2 (Medical Device) means in your sector
What MDS2 (Medical Device) means for your job
Questions people ask about MDS2 (Medical Device)
What is MDS2?
How many controls does MDS2 have?
Where does MDS2 apply?
What frameworks does MDS2 map to?
How do I get started with MDS2 compliance?
Query MDS2 (Medical Device) programmatically
MDS2 (Medical Device), its 25 controls and every mapping into other standards are available over a REST endpoint and an MCP server, so an agent can read them directly. The free tier is 10 calls a day and needs no signup.
MDS2 (Medical Device) API reference and MCP config →What MDS2 (Medical Device) requires, control by control
Each page carries the requirement text for one MDS2 (Medical Device) control and what an assessor expects to see as evidence.
- AUDIT-LOGGING-AUDT-INTEGRITY-IGAU-CYBERSECURITY-RISK-CYBR-MONITORING MDS2 Audit Controls + AUDT + Integrity + IGAU + Cybersecurity Risk + CYBR + Continuous Monitoring
- PERSON-NODE-AUTHENTICATION-AUTHORIZATION-AUTO-LOGOFF-AUTH-PAUT-NAUT MDS2 Authentication + Authorization + Auto Logoff + PAUT + NAUT + AUTH + Identity Management
- 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-PLOK-WORKSTATION-DISPOSAL-BACKUP-DTBK-DISASTER-RECOVERY MDS2 Physical Security + PLOK + Workstation + Disposal + Backup + DTBK + Disaster Recovery
- ROADMAP-THIRD-PARTY-RDMP-SECURITY-GUIDANCE-SGUD-SBOM-VULNERABILITY-DISCLOSURE-PROGRAMME MDS2 Roadmap + RDMP + Third Party + Security Guidance + SGUD + SBOM + Vulnerability Disclosure + Coordinated
How ready are you for MDS2 (Medical Device)?
Answer 25 questions and get a professional readiness report with gap analysis, maturity scores, and prioritised action items. Results in 5 minutes.