Module 14 2022

22/03/2022

GOOD DESIGN PRACTICE

DESIGN INPUTS ● RISK MANAGEMENT (ISO 14971) – AN ONGOING PROCESS – VERY IMPORTANT FROM THE START ● Identify

– PERCEIVED risks – IDENTIFIED risks ● MITIGATE THE RISKS – Secondary assessments to mitigate further? – Feedback to the IFU

Masterclass: Lecture 1

The Organisation for Professionals in Regulatory Affairs

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GOOD DESIGN PRACTICE

DESIGN OUTPUTS

● US LEGISLATION 21CFR 820.3 (g): – “Design output means the result of a design effort at each design phase and at the end of the total design effort..”

– “The total finished design output consists of the device, its packaging and labeling, and the device master record” (DMR)

Masterclass: Lecture 1

The Organisation for Professionals in Regulatory Affairs

38

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