Manage device lifecycle evidence and regulatory responsibilities with strong change control.
Begin with one specific outcome. Ask who experiences the current problem, what evidence would show it, and which decision or process could change. Assign an owner and set a date to review the effect.
Describe the current work and the result it produces.
Gather a small set of real examples and involve the people doing the work.
Choose a proportionate change with an owner and a measure.
Review the result, unintended effects and next decision.
A quality management system focused on medical-device safety and performance across design, manufacture and post-market activity. Read the standard context
ISO 13485
Supplier qualification
A quality management system focused on medical-device safety and performance across design, manufacture and post-market activity. Read the standard context
These are suggested evidence areas, not a checklist proving conformity. Choose what is material to your work and verify the current edition with the publisher.