Module 14 2022

22/03/2022

Device Design

History of Development • Origins of the Device • Design and Development Process • Reviews of design (including those that were no pursued or didn’t work) • Changes

Design Sites • Which manufacturers have been involved in development? • Include their manufacturing licenses/accreditation • Quality Management System

This is why it is necessary to document learnings and data from the design and development process .

Masterclass Lecture 8

The Organisation for Professionals in Regulatory Affairs

17

Device Design

This section walks the reviewer through the rationales applied to reach the final Device design. …and is backed by the supporting documents in your design file that recorded: • DESIGN DECISIONS • 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 “If you haven’t written it down, you haven’t done it”

Masterclass Lecture 8

The Organisation for Professionals in Regulatory Affairs

18

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