ARTICLE SUMMARY:
In this edition of Consultants Corner, insights on US, EU, and UK regulatory strategies from Michelle Lott, Gert Bos, and Matt Burton, who each spoke at the 2024 MedTech Regulatory Global Pathways Virtual Summit earlier this month.
Welcome to Consultants Corner, where we check in with independent experts about questions they are answering or challenges they are solving for clients on the front lines of medtech regulatory, reimbursement, and market access.
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Gert Bos is CSO, executive director, and partner with Qserve Group in the Netherlands, and previously served in top roles at BSI and other EU notified bodies.elligence, strategic advice, and other services.
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Bringing new and updated devices and diagnostics to market raises a raft of regulatory challenges and decision points. One key variable is geography. It’s crucial for medtech firms to recognize that the requirements they face in each region will be different and, on top of that, are frequently evolving.
On February 7, Market Pathways and MedTech Leading Voice co-sponsored the MedTech Regulatory Global Pathways Virtual Summit to address regulatory challenges and opportunities in the three regions, as well as areas of overlap and misalignment. Executive Editor David Filmore moderated presentations and discussion with Matt Burton, IMED Consultancy, who focused on the UK; Gert Bos, PhD, from Qserve Group, who addressed the current state of EU regulations; and Michelle Lott, founder of Lean RAQA, who covered the US FDA framework. Check out a recording of the full event (passcode: 2ifQ%zS*). In this article, we spotlight some segments of the conversation with experts’ tips for global go-to-market strategies and thoughts on harmonization opportunities.
