Think global, buy local…and local for me is the San Francisco, California USA area.
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.
I can think of 3 options when engineering specification (design verification spec) is not met.
Unfortunately, there is currently no centralized database to search Notified Bodies and their Client companies. Here are some ideas for how to go about this.