Quality System and 

Design Control

• Objective:  Safe and effective product

• QS – Specific for a given product

• Integrative from beginning to end

• Dynamic (current) according to feedback

• Achieve a state-of-control environment

• In accordance to: 

  • CFR 21 Part 820  (FDA)

  • ISO 9001/13485 (EU)

The easy way to remember is that MDR 13485 is a superset of FDA Design Control 21 CFR Part 820.  So you must at least be familiar with FDA Design Control 21 CFR Part 820.