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ISO 13485:2016 — Medical devices QMS

The medical-devices quality management standard. Mandatory for CE marking under EU MDR/IVDR and FDA registration in the US.

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A sector add-on over ISO 9001 — adds medical-device-specific quality requirements, design and development controls, risk management linkage to ISO 14971, and post-market surveillance.

Required for:

  • EU CE marking under MDR (Reg. 2017/745) and IVDR (Reg. 2017/746)
  • FDA registration in the US (21 CFR Part 820, now aligned with ISO 13485)
  • Health Canada, TGA Australia, and most other jurisdictions

The first non-Annex-SL standard in the catalogue — the medical-device industry kept its own pre-existing structure rather than adopting the harmonised Annex SL.