Module 14 2022

22/03/2022

GOOD DESIGN PRACTICE

TYPICAL DESIGN OUTPUTS (2) ● Component and materials specifications ● Equipment calibration and preventive maintenance requirements ● Results of risk analysis ● Results of biocompatibility testing ● Prototypes for verification and / or validation ● Results of verification.

Masterclass: Lecture 1

The Organisation for Professionals in Regulatory Affairs

43

GOOD DESIGN PRACTICE

DESIGN VALIDATION ● Validation

– Confirmation by examination and provision of evidence that the particular requirements for a SPECIFIC INTENDED USE can be consistently met. ● DESIGN validation – Confirmation that the device meets the user needs and intended uses. – Did I make the right product and can I prove it?

Masterclass: Lecture 1

The Organisation for Professionals in Regulatory Affairs

44

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