The agency anticipates the program will result in a two-thirds reduction of the amount of device malfunction reports submitted by manufacturers.
When it comes to adverse event reporting, the FDA does not grant exemptions.
How in touch are you with current MDR guidelines?
If your firm does not have an MDR procedure, FDA will find out.
Never downplay the importance of customer complaints.
The document clarifies the MDR regulation and reporting requirements for medical device companies.
Define, document and implement!
Are you UDI-ready? Get the facts to achieve compliance fast.
A review of the important aspects of risk management and post-market surveillance processes, and how to resolve common concerns.
You must have established procedures for complaint management and MDRs.