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...
Regulatory
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...
5 min read
Leveraging AI and ML in Medical Products – Part 2
Bob Bouthillier Director, Electrical Engineering, Veranex
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...
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...
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...
3 min read
Amending Regulation for MDR / IVDR: Key Takeaways for the Diagnostics Industry
The EU Parliament adopted the regulation amending EU 2017/745 (MDR) and EU 2017/746 (IVDR) aiming to protect patients by ensuring the availability of...
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,...
2 min read
Prioritizing Patient Safety and Fostering Innovation with the MHRAs New Roadmap for Medical Devices
On January 9, the United Kingdom (UK)’s Medicines and Healthcare Products Regulatory Agency (MHRA) released a regulatory framework – Roadmap towards...
2 min read
New Proposal for Extended Transition Periods for IVDs: Can Manufacturers Slow Down Transition Efforts?
On 23 January 2024, the EU Commission published a new proposal for amending the regulations EU 2017/745 (MDR) and EU 2017/746 (IVDR) aiming to...