Module 14 2022

22/03/2022

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

29

● 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 In the early stages of development, you will not have all the information that you need, but this should prompt you to identify a need within your DESIGN PLAN

Masterclass: Lecture 1

The Organisation for Professionals in Regulatory Affairs

30

15