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Unit 11 of 17

The Quality System & Risk

How a company stays in control: ISO 13485 and the new US QMSR, documents and records, ISO 14971 risk management, complaints and reporting deadlines, CAPA that goes beyond retraining, suppliers, audits and post-market surveillance. Then follow a signal that only the registry could see.

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8 hands-on lessons, then a case · about 30–45 minutes

A knee tray, an audit clipboard and a red hold tag

What you’ll learn

  1. 01The quality system
  2. 02Documents and records
  3. 03Hazard to harm
  4. 04Complaints
  5. 05Report — and how fast?
  6. 06CAPA, not retraining
  7. 07Suppliers and audits
  8. 08Watching after launch