Module 14: Design Development and Certification of Medical Devices

17/11/2023

Start to prepare your initial IFU (3) ..and design aspects..

● If sterile – what to do if the package is damaged ● Instructions for: – Sterilisation – if required. – Re-use / cleaning / disinfection / packaging – How to identify when the device can no longer be re-used.

● Information on use with other devices

● Radiation protection information

Masterclass: Lecture 1

The Organisation for Professionals in Regulatory Affairs

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● Warnings, precautions and limitations of use – Related to actual or foreseeable risks Start to prepare your initial IFU (4) ..and design aspects..

● How to dispose of the device and its components

● Information on when a lay person should consult a healthcare professional

Masterclass: Lecture 1

The Organisation for Professionals in Regulatory Affairs

30

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