F
fondantcookie
Hi all,
I'm relatively new to RA but worked within IVD manufacture for nearly 10 years.
I work for a medical devices company and I've been tasked with leading a gap analysis of our quality management system against the FDA regulations (CFR 820 Part 21?), in preparation for us applying for FDA registration.
Do any of you have a good starting point for this for example a checklist? Or some sort of comparison against ISO13485?
ANY advice would be greatly appreciated at the point.. just wandering in the dark at the minute. Haha
Cheers,
Peter
I'm relatively new to RA but worked within IVD manufacture for nearly 10 years.
I work for a medical devices company and I've been tasked with leading a gap analysis of our quality management system against the FDA regulations (CFR 820 Part 21?), in preparation for us applying for FDA registration.
Do any of you have a good starting point for this for example a checklist? Or some sort of comparison against ISO13485?
ANY advice would be greatly appreciated at the point.. just wandering in the dark at the minute. Haha
Cheers,
Peter