What ISO 13485:2016 Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes requires
ISO 13485:2016 requires medical device manufacturers to establish a quality management system that meets regulatory requirements, as outlined in Clause 4.1, and to implement risk management processes, as specified in Clause 7.1.
Pillar: Pharmaceuticals & Life Sciences · Authority: International Organization for Standardization (ISO) · Version: 1.0.0 · Last updated:
Primary source: https://www.iso.org/standard/59752.html
SHA-256 integrity: 5b5d362ee81ad9e71bd14f394215d58d40e621b06aeebe137fccce5665473fbe
Primary Citations — 8 traced to source
- ISO 13485:2016, Clause 4.1 - Quality Management System
- ISO 13485:2016, Clause 7.1 - Risk Management
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