RAPS

Medical Device Validation: What You Need to Know and Why It's Important

Inadequate process validation is one of the most common issues leading to warnings from the US Food and Drug Administration (FDA). It may also be the most difficult to address, according to Max ...
MD&M East

How to Use Surrogate Devices for Validation of Destructive Test Methods for Combination Product Design Verification

Laboratory-based design verification testing (DVT) of combination products and medical devices must be performed to demonstrate that the device meets the performance requirements that were set in the ...
RAPS

FDA Unveils List of Reusable Devices Requiring New Validation Data

Following superbug outbreaks after issues with reprocessing certain medical devices, the US Food and Drug Administration (FDA) on Thursday released a list of devices that the agency will require ...