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4 min read

Giving Back

Nicolas Borenstein, DVM, Ph.D. Co-President, Preclinical Services “We are not a veterinary clinic and our primary mission is indeed to validate medical devices and novel therapeutic strategies in clinically relevant large animal preclinical models....

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3 min read

How to Design an Efficient Preclinical Testing Study

A medical device’s pathway from concept to commercialization can be fraught with pitfalls, setbacks, and a need to recurring, significant...

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4 min read

How Confounding Forces Impact Medical Device Development

Bob Bouthillier Director, Electrical Engineering, Veranex We live in a time where we have easy access to biometrics that help both our clinicians and...

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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...

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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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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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4 min read

Key Insights on the Challenges of Whitespace Innovation

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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