Module 14: Design Development and Certification of Medical Devices

17/11/2023

Content of the STED

MDR Annex II and III Detailed Structure of STED described in IMDRF 2019 Guidance • Device Description (including development history) • Indications for use • Non-clinical Evidence • Risk Management • Essential Principles Checklist (GSPR) • Non-clinical studies • Clinical Evidence • Labelling and Promotional Material • Quality Management System

Masterclass Lecture 8

The Organisation for Professionals in Regulatory Affairs

11

Snapshot of STED layout

Adapted from IMDRF, 2019

Masterclass Lecture 10

The Organisation for Professionals in Regulatory Affairs

12

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