ISO 13485
What is ISO 13485?
Medical devices - Quality management systems.
How ISO 13485 maps to other frameworks
Every control, 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 →How ISO 13485 groups its controls
Frameworks that share controls with ISO 13485
Each of these has at least one control mapped to a control in ISO 13485. The number is how many ISO 13485 controls are shared, counted from the mapping graph.
NIST SP 800-66
13 shared controlsMDS2 (Medical Device)
13 shared controlsMARS-E
13 shared controlsISO 27799
13 shared controlsNIST Privacy Framework
12 shared controlsOman National Cybersecurity Framework
11 shared controlsFTC GLBA Safeguards Rule (16 CFR Part 314)
11 shared controlsTISAX - Trusted Information Security Assessment Exchange
11 shared controlsWhere ISO 13485 overlaps with the standards you already hold
Where to get trained on ISO 13485
4 courses in the catalogue cover ISO 13485 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 24 ISO 13485 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 ISO 13485 evidence request listWhat ISO 13485 means in your sector
What ISO 13485 means for your job
Questions people ask about ISO 13485
What is ISO 13485?
Where does ISO 13485 apply?
What frameworks does ISO 13485 map to?
How do I get started with ISO 13485 compliance?
Query ISO 13485 programmatically
ISO 13485 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.
ISO 13485 API reference and MCP config →How ready are you for ISO 13485?
Answer 25 questions and get a professional readiness report with gap analysis, maturity scores, and prioritised action items. Results in 5 minutes.