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Management system · 2016 edition

ISO 13485

Medical devices quality management for regulatory purposes. The published edition is still 2016. This register is not an FDA or MDR submission.

  • Record

    The device quality system

  • The standard

    ISO 13485:2016

  • Where it is used

    On the clause register

What it does

  • Medical devices quality management for regulatory purposes.
  • The published edition is still 2016 and was reconfirmed.
  • This register is not an FDA or MDR submission, and this software does not certify a device.

On the record

  • Turn the standard on only if you hold it, or you are working towards it.
  • A clause is not started, a gap, in progress, or evidenced.
  • Readiness is the share of evidenced clauses. ISO 31000 is not in that score.

The standard

  • ISO 13485:2016

    Medical devices. Not an FDA or MDR submission. The app does not certify a device.

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