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Unit 10 of 17

Design Controls & Testing

How a new implant is designed and proven: user needs, measurable inputs, verification and validation, FDA’s pass marks for screws and plates, worst-case testing, traceability and design reviews. Then chair the review for a plate that fails by 4%.

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

A plate prototype, an engineering drawing, a calliper and a bone model

What you’ll learn

  1. 01From needs to inputs
  2. 02Spec it
  3. 03Verify or validate?
  4. 04Pass marks: screws
  5. 05Pass marks: plates
  6. 06The worst case
  7. 07Trace it
  8. 08Reviews and files