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Advancements in Medical Robotics: Game-Changing Medical Innovation Insights from Our PDE Group
Institutions and enterprises around the world are pushing the boundaries of medical innovation by applying advanced robotic technologies to address...
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Identification, Engagement and Commitment of Key Players for a Successful Preclinical Study
Assembling a team for an efficient preclinical study When it comes to kicking off your preclinical study, assembling the right team will help you...
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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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Leveraging AI and ML in Medical Products – Part 2
Bob Bouthillier Director, Electrical Engineering, Veranex
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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...
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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...
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2024 IVDR Sprint: 6 Reasons Why You Should Start a Performance Evaluation Early
In accordance with Article 5(3) of Regulation (EU) 2017/746 (IVDR), a performance evaluation must be drawn up for every IVD placed on the European...
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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...
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Biocompatibility of Medical Devices: Process, Detailed Steps and 7 Hot Topics to Crack the Code of Medical Device Safety
The landscape of modern healthcare has been completely transformed by the development of cutting-edge medical devices. From life-saving implants to...