Regulatory pathway · all topics

ISO 13485:2016 Medical Device Quality Management Systems

ISO 13485:2016 specifies requirements for a QMS where an organization demonstrates ability to provide medical devices and related services that meet customer and applicable regulatory requirements. Aligned with FDA QSR but with explicit medical device focus including risk management throughout product realization, design controls, validation of processes, and post-market activities. Certification is required for CE marking under MDR/IVDR. Differs from ISO 9001 in mandatory documented procedures and risk-based approach.

Source

ISO 13485:2016 'Medical devices - Quality management systems - Requirements for regulatory purposes'

https://www.iso.org/standard/59752.html

How MedTek OS handles this

Compass drafts the iso 13485:2016 medical device quality management systems workflow with confidence-gated content.

The platform refuses to generate content below the threshold for this artifact class. Every claim carries a citation chain back to RIG, audit-logged with HMAC integrity.

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