Veranex Blog

1 min read

What is Fast to Proof-of-Concept?

We see a continued need from our clients, both large and small, to partner with organizations that can deliver meaningful and actionable solutions focusing on usa bility, design , and engineering in phase 0 through phase 2 front-end engagements....

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6 min read

Leveraging AI and ML in Medical Products – Part 3

Bob Bouthillier Director, Electrical Engineering, Veranex In this three-part series, Bob Bouthillier discusses the state of artificial intelligence...

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5 min read

Leveraging AI and ML in Medical Products – Part 2

Bob Bouthillier Director, Electrical Engineering, Veranex

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4 min read

Achieving Regulatory Clearance for a Novel Device – Provisio Medical

Provisio™ SLT IVUS™ System Creating a novel medical device typically includes innovation around treatment, capabilities, cost reduction, or usability...

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6 min read

Leveraging AI and ML in Medical Products – Part 1

Bob Bouthillier Director, Electrical Engineering, Veranex In this three-part series, Bob Bouthillier discusses the state of artificial intelligence...

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6 min read

Building Blocks of Quality: The Role of Design Control in Medical Device Development

Design Control is a critical quality management system process that allows for a concept be developed and evolve into a reliable and safe product...

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1 min read

Playing Defense: Cybersecurity for Diagnostic Devices

No industry or device is immune from the risk of cyber attacks. And it’s especially important that medical devices including diagnostic instruments...

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3 min read

Expert Insights: Project Management with Matt Perry

Recently we sat down with Matt Perry, VP of program management at Veranex, to talk about common project management issues within medtech, and his...

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2 min read

Ensuring Compliance with New FDA Guidance on Software Documentation & Cybersecurity

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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2 min read

Clinical Utility Evidence Planning: Framework, Assessment Techniques, and Case Study for a Diagnostic Test

Clinical utility describes the usefulness of a medical product (device, diagnostic/prognostic, or therapeutic) for physicians and/or patients, and...

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