Module 14 2022
22/03/2022
DOCUMENTING THE DEVICE DEVELOPMENT
DEVICE DEVELOPMENT INFORMATION IS USED: ● TO CONSTRUCT THE DESIGN HISTORY FILE ● TO SUPPORT PATENT ACTIVITIES
IT IS REALLY IMPORTANT TO RECORD: ● DESIGN DECISIONS ● DESIGN CONTROLS
Masterclass: Lecture 1
The Organisation for Professionals in Regulatory Affairs
23
THE IMPORTANCE OF DOCUMENTING THE DEVICE DEVELOPMENT
● DESIGN DECISIONS – INVESTIGATIONS THAT WORKED – AND THOSE THAT DID NOT
– LEARNINGS FROM THE DATA GENERATED – And how they influenced the next steps – RISKS MITIGATED / NEW RISKS IDENTIFIED – To understand the WHOLE picture – STUDIES TO CONFIRM COMPLIANCE WITH REGULATORY STANDARDS – Mandatory requirement! – INNOVATIVE APPROACHES – What clever solutions have you used?
Masterclass: Lecture 1
The Organisation for Professionals in Regulatory Affairs
24
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