Module 14 2022

22/03/2022

Certification: Developing documentation to support regulatory assessment of a new device

Jason Collins, Director, ESPL Regulatory Consulting

The Organisation for Professionals in Regulatory Affairs

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Learning Outcomes

• Understand what information is needed by regulators • How the Product Design File translates to the STED file • The structure and content of the STED file • Transferability of the documentation in the STED file

Masterclass Lecture 8

The Organisation for Professionals in Regulatory Affairs

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