Module 14 2022

22/03/2022

GOOD DESIGN PRACTICE

DESIGN OUTPUTS ● When?

– End of the feasibility process – Product performance specification (PPS) [also TPP] – Prior to performing biocompatibility testing – Development of test protocol or method (output) – .. Which is then used to conduct the testing (input) – Prior to conducting a Human Factors / User Study – Manufacture of prototype (output)

– At the end of the design transfer phase – These outputs serve as inputs to manufacturing and product realisation

Masterclass: Lecture 1

The Organisation for Professionals in Regulatory Affairs

39

GOOD DESIGN PRACTICE

DESIGN OUTPUTS ● Regulated under ISO 13485 / ISO 9001 / 21CFR 820.30(d) ● Design outputs must – Meet design input requirements – Provide information for product realisation – Contain or refer to acceptance criteria – Identify critical device characteristics essential to the safe and proper use of the device. – Including handling, storage, maintenance etc.

Masterclass: Lecture 1

The Organisation for Professionals in Regulatory Affairs

40

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