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...
Product Development (2)
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...
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...
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...
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...
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...
2 min read
Appropriate, early planning for medical device development could help outshine the darkness of Alzheimer’s disease
Exciting developments in the area of medical devices for the diagnosis, prognosis, treatment/management, and monitoring of Alzheimer’s disease (AD)...
5 min read
Nanomaterials in Medical Devices: Biological Risks and Methodology for Biocompatibility Assessment
Introduction Nanomaterials, tiny scientific wonders that are invisible to the naked eye, hold the potential to revolutionize numerous facets of our...