This should be one of the first questions asked during the medical device development process.
Europe MDR 2017/745 General Req vs. MDD 93/42/EEC Essential Req
The Annex I “Essential Requirements” of the European medical device directives have been supercharged and reincarnated
Quality System Process Risk Management (ISO 13485:2016)
ISO 13485:2016 has a broader view of risk management than in the past.
Transitioning to ISO 13485:2016
Now is the time to get the 13485 monkey off your back.
Europe Medical Devices Regulation (MDR) 2017/745 with Table of Contents and Bookmarks
Did you notice that the published regulation does not have a table of contents or bookmarks?
Quality Policy and Objectives
Does your organization’s Quality Policy inspire you, or tire you? Are you Quality Objectives follow a framework established by the Policy statement?