Module 14 2022

22/03/2022

Your initial IFU

● 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

31

GENERAL SAFETY & PERFORMANCE REQUIREMENTS (GSPR)

A CRITICAL REGULATORY / PLANNING DOCUMENT USED TO IDENTIFY: ● REQUIREMENTS RELEVANT TO THE DEVICE ● THE ISO AND OTHER REGULATORY STANDARDS APPROPRIATE TO THOSE REQUIREMENTS ● THE TYPE OF DATA (Later the actual data) THAT WILL CONFIRM COMPLIANCE WITH THE RELEVANT STANDARDS

Masterclass: Lecture 1

The Organisation for Professionals in Regulatory Affairs

32

16