Module 18 - Drug Device Combinations and Other Technologies

13/12/2023

IMDRF

http://www.imdrf.org/

The Organisation for Professionals in Regulatory Affairs

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The DDC technical file (STED) – device aspects

Manufacture and control in accordance with ISO standards

• Evidence of compliance with ISO standards, including: • ISO 14971 (Risk Mgt)

• ISO 13485 (Quality Mgt system) • ISO 10993 – relevant sections (Biological evaluation of medical devices) • Clinical evaluation report • Labelling, etc..

The Organisation for Professionals in Regulatory Affairs

32

16