Frequently Asked Questions
Do I have to implement a quality system for a Class I device?
It depends on the requirements of the FDA classification regulation/product code. (need more info, See earlier comment)
Is ISO 13485 sufficient?
The FDA does not recognize ISO 13485 as being in compliance with FDA QSR (21 CFR part 820). Furthermore, ISO 13485 certifications are not equivalent to FDA QSR compliance.
Can I wait to implement GMP until after my product is registered?
This is not recommended. Once your product is registered with the FDA you become subject to random FDA inspections. Also, to comply with requirements related to design control, you should implement a quality management system early in the device development process.