Hi all,
Looking for thoughts and advice please!!
We are a UK based manufacture of a Class I medical device, currently no ISO 9001 or 13485
Submission for 510k file indicate Class 2 FDA device. We are happy to go along with this as we have all relevant testing data etc.
What I am looking for is the FDA QS requirements, I am gearing up the systems to be 13485 compliant however with the cost (and timelines) there is a reluctance from the board to progress forward with 13485 certification through a notified body.
Are there any requirements from the FDA to have a certified Quality Management System for an FDA Class 2 device?
Look forward to your thoughts on this
Looking for thoughts and advice please!!
We are a UK based manufacture of a Class I medical device, currently no ISO 9001 or 13485
Submission for 510k file indicate Class 2 FDA device. We are happy to go along with this as we have all relevant testing data etc.
What I am looking for is the FDA QS requirements, I am gearing up the systems to be 13485 compliant however with the cost (and timelines) there is a reluctance from the board to progress forward with 13485 certification through a notified body.
Are there any requirements from the FDA to have a certified Quality Management System for an FDA Class 2 device?
Look forward to your thoughts on this