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. 23, 2025 (GLOBE NEWSWIRE) -- The "Bottlenecks to Flow: Optimizing Design Controls and Validation in Medical Device QMS (Oct 23rd - Oct 24th, 2025)" training has been added to ...
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 ...
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 ...
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 ...
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 ...
A well-repeated truism throughout the semiconductor industry is that chip design verification is complex and often takes up the largest portion of a design project’s schedule –– sometimes as much as ...
SAN FRANCISCO, April 7, 2020 /PRNewswire/ -- The global medical device validation and verification market size is expected to reach USD 1.1 billion by 2027, expanding at a CAGR of 11.1% over the ...
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