Becker's Hospital Review

White Paper Discusses Reusable Medical Device Cleaning Validation, Testing Requirements

Microtest Laboratories has issued a management brief that discusses reusable medical device cleaning validation and testing practices in view of the FDA’s own discussions and actions around ...
MD&M East

Electronics Cleaning Validation: Ensuring Quality & Safety in Medical Device Manufacturing

Medical device equipment manufacturers work in an environment where product quality isn't just a competitive advantage, it's a regulatory necessity with direct implications for patient safety. As ...
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 ...
JD Supra

FDA Signals Major Shift for QMSR Transition for Medical Device Applications

Brendan Carroll, Jessica Ritsick, Jong Ho "Philip" Won, Ph.D. Our FDA: Drug & Device Team provides recommendations based on Food & Drug Administration (FDA) draft guidance on Quality Management System ...