Module 14 2022

22/03/2022

• Instructions for Use • Key information to ensure safe and correct use of the device • Wording must be simple and easy to understand • Use a design that is easy to read • Labelling on the device • Labelling of the container • Mock-ups of the labels/containers • Physician labelling / e-labelling / operators manuals • Other training materials Labelling and Promotional Material

Masterclass Lecture 9

The Organisation for Professionals in Regulatory Affairs

29

Quality Management System

2 parts: • Overall Quality Management System procedures • QMS Device-specific information

Includes summary of procedures in place to ensure manufacture, change control, safety monitoring are in place ISO 13485 compliance

Masterclass Lecture 8

The Organisation for Professionals in Regulatory Affairs

30

15