The FDA Center for Devices and Radiological Health (CDRH) March 11, 1997 issued the Guidance “Design Control Guidance for Medical Device Manufacturers“. This guidance is key to understand and implement today.
The FDA Center for Devices and Radiological Health (CDRH) March 11, 1997 issued the Guidance “Design Control Guidance for Medical Device Manufacturers“. This guidance is key to understand and implement today.