Veranex Blog

FDA Regulatory

6 min read

Navigating FDA’s Latest Guidance Updates for AI-Enabled Medical Devices: A Marketing Submission Guide

As artificial intelligence transforms healthcare innovation, the FDA continues to evolve its regulatory framework for AI-enabled device software...

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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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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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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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1 min read

Document Review: A Nuanced Process in Medical Writing

Veranex is determined to provide complete support to our healthcare partners to reach our shared goal of advancing medical care and improving...

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4 min read

Built to Fit Your Needs: Our CDMO Capabilities

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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