6 min read
Design Control is a critical quality management system process that allows for a concept be developed and evolve into a reliable and safe product that can be consistently and reproducibly produced for commercial use. The process uses a systematic...
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No industry or device is immune from the risk of cyber attacks. And it’s especially important that medical devices including diagnostic instruments...
2 min read
New guidance from the FDA replaces similar, but now obsolete, guidance. Some of the guidance was issued in response to the PATCH Act, which is a 2022...
2 min read
Clinical utility describes the usefulness of a medical product (device, diagnostic/prognostic, or therapeutic) for physicians and/or patients, and...
4 min read
We recently sat down with three big-picture thinkers at Veranex to talk about whitespace innovation — its challenges, how we’ve seen it done...
2 min read
Anyone who works in medtech product development knows that surprises are a guarantee. That’s why it’s important to create stability and...
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Atrial fibrillation remains a leading cause of death and disability and the most common type of arrhythmia. While radiofrequency ablation and...
3 min read
Our approach to Quality Management ensures that we’re always speaking the same language.
4 min read
Learn about our capabilities and offerings as a CDMO We sat down with Bill Croisetiere (VP, Integrated Supply Chain), Chris Vigneau (VP,...
5 min read
Medical Device Software (MDSW) is a growing, fast-evolving industry. However, manufacturers must often face a regulatory framework which does not...
