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 ...
When it comes to verification and validation, medical device companies need to ensure that what they're doing actually makes sense. Known colloquially as "V&V," for many it feels like you're on the ...
Dublin, Sept. 22, 2025 (GLOBE NEWSWIRE) -- The "US FDA Medical Device Quality System (QSR) Compliance: Design Controls, Verification & Validation (Oct 27th - Oct 28th, 2025)" training has been added ...
DUBLIN--(BUSINESS WIRE)--The "Verification and Validation - Product, Equipment/Process, Software and QMS" training has been added to ResearchAndMarkets.com's offering. This seminar will provide ...
Resonetics experts explain the different stages of nitinol’s journey as it becomes part of a life-changing medical device.
Formal methods provide a rigorous mathematical foundation for the specification, development and verification of medical device software. This approach enhances both reliability and safety, which are ...
Market opportunities arise in providing solutions for cGMP software verification and validation, addressing increased FDA scrutiny. Demand exists for expertise in FDA guidelines, risk management ...
Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...
FDA’s 21 CFR Part 820 — Quality System Regulation (QSR) has not been updated since it was first released in 1996 . . . until now. Are you ready? Part of a panel at the conference discussing the ...