ISO 13485
What is ISO 13485?
Medical devices - Quality management systems. It comprises 29 controls organised across 11 domains, published by ISO/IEC, and applies in International.
How ISO 13485 maps to other frameworks
All 29 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 11 domains ISO 13485 groups its controls into
Where 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.
What ISO 13485 means in your sector
What ISO 13485 means for your job
Questions people ask about ISO 13485
What is ISO 13485?
How many controls does ISO 13485 have?
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, its 29 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.
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.