Veranex Blog

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 investments. Our preclinical teams are often asked by prospective sponsors for in-vivo preclinical studies that...

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4 min read

Scope of Statistical Applications in Risk-Based Quality Management (RBQM)

Risk-based quality management (RBQM) represents a core area of clinical development that systematically focuses on both safety and data quality risks...

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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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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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