This should be one of the first questions asked during the medical device development process.
The Annex I “Essential Requirements” of the European medical device directives have been supercharged and reincarnated
ISO 13485:2016 has a broader view of risk management than in the past.
Now is the time to get the 13485 monkey off your back.
Did you notice that the published regulation does not have a table of contents or bookmarks?
Does your organization’s Quality Policy inspire you, or tire you? Are you Quality Objectives follow a framework established by the Policy statement?