Yes, there is a link between Form 483 observations and failing to conduct management reviews.
Failure to investigate complaints is a major compliance failure.
As software becomes more complex and connected, device manufacturers must address more risks.
In Part I of our ISO 13485 test, see how much you know about the basics of the standards.
Getting through the complex maze of regulatory requirements can be an overwhelming process for any medical device company.
A three-part series on quality system remediation and what manufacturers need to do to get through the process.
Do regulators have a disincentive to approve medical devices?
An FDA inspection should never be confused with a notified body audit.
Having a comprehensive plan in place and conducting mock recalls can help a device company protect its brand before it’s too late.
FDA offers help on when and what type of clinical evaluation is appropriate for SaMD.