Module 14: Design Development and Certification of Medical Devices

17/11/2023

Module 3.2.R USA ● Batch record sheets ● Comparability protocols ● Methods validation EU ● Process validation scheme ● Medical device – EU Declaration of conformity

– Applicant’s Declaration (Class I: EXCEPT IM, ISS, IRSI) – NBOp (NB opinion) on conformity of the device with GSPRs ● Certificates of Suitability ● TSE Certification

Masterclass Lecture 8

The Organisation for Professionals in Regulatory Affairs

43

Learning Outcomes: Recap

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

Masterclass Lecture 8

The Organisation for Professionals in Regulatory Affairs

44

22