This is a passage from the training course “Intro to Layout Control for Medical Instruments” which is offered at:
Learn more concerning why you must do make control right here:
00:18 About the teacher
00:50 Introduction to develop control for clinical gadgets
01:07 Is layout control needed?
02:48 What is layout control?
03:45 21 CFR 820 or Quality system guideline (QSR) in the United States
04:07 ISO 13485 requirement on high quality administration systems in the EU
04:41 Design control in United States vs EU
05:05 Competent authorities
06:24 Additional assistance and also sources