Think global, buy local…and local for me is the San Francisco, California USA area.
Tag: quality system
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.
Damn…we failed verification testing!
I can think of 3 options when engineering specification (design verification spec) is not met.
Notified Body Sleuthing
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.