Module 14 2022

22/03/2022

NANOMATERIALS..

EU RECOMMENDATIONS:

Masterclass: Lecture 3

The Organisation for Professionals in Regulatory Affairs

29

● CHOICE OF MATERIALS HAS A CRUCIAL IMPACT ON ALL ASPECTS OF THE FUNCTIONALITY / USABILITY OF A DEVICE IT IS REALLY IMPORTANT TO RECORD: ● The DESIGN DECISIONS underlying choice of materials, and… as previously discussed – INVESTIGATIONS THAT WORKED AND THOSE THAT DID NOT – LEARNINGS FROM THE DATA GENERATED – RISKS MITIGATED / NEW RISKS IDENTIFIED – STUDIES TO CONFIRM COMPLIANCE WITH REGULATORY STANDARDS – INNOVATIVE APPROACHES ● DESIGN CONTROLS Reminder! DOCUMENTING THE DESIGN PATHWAY

Masterclass: Lecture 3

The Organisation for Professionals in Regulatory Affairs

30

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