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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 combine a robust cyber security post-market release plan with software applications to support data...
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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...
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Clinical utility describes the usefulness of a medical product (device, diagnostic/prognostic, or therapeutic) for physicians and/or patients, and...
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We recently sat down with three big-picture thinkers at Veranex to talk about whitespace innovation — its challenges, how we’ve seen it done...
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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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CT Image of Pulmonary Veins Atrial fibrillation remains a leading cause of death and disability and the most common type of arrhythmia. While...
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Our approach to Quality Management ensures that we’re always speaking the same language.
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Learn about our capabilities and offerings as a CDMO We sat down with Bill Croisetiere (VP, Integrated Supply Chain), Chris Vigneau (VP,...
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Medical Device Software (MDSW) is a growing, fast-evolving industry. However, manufacturers must often face a regulatory framework which does not...
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The human factors team at Veranex has reviewed the NMPA Guidance Draft 01 and Draft 02 and submitted feedback to the agency. We’re committed to...
