I may provide QMS consulting for a startup medical device customer in France. We are working on developing a QMS while planning out a timeline and regulatory pathway.
This may seem a simple question that I could determine myself by looking closely at the new EU MDR regulations, but can anyone tell me whether a company needs to either pass an EU audit or become ISO 13485 certified before they can perform human clinical trials?
Can you link me or attach a document that spells out the process and document requirements?
Thank you.
This may seem a simple question that I could determine myself by looking closely at the new EU MDR regulations, but can anyone tell me whether a company needs to either pass an EU audit or become ISO 13485 certified before they can perform human clinical trials?
Can you link me or attach a document that spells out the process and document requirements?
Thank you.