Live! #89 – Compliance for EU Market Access with BSI, Brabners, and RQM+

NOV 3, 202562 MIN
Making MedTech Happen with RQM+

Live! #89 – Compliance for EU Market Access with BSI, Brabners, and RQM+

NOV 3, 202562 MIN

Description

<p><em>This panel was recorded September 18, 2025.⁠⁠⁠⁠ We hope you&#39;ll join us live in the future to ask your own questions and participate in the attendee chat! See similar events on demand and read other free MedTech resources at </em><a href="https://www.rqmplus.com/resources/">⁠<em>RQMplus.com</em>⁠</a><em>.</em></p><p><br></p><p>Manufacturers often focus on MDR or IVDR and miss cross-cutting EU laws that impact CE marking, technical documentation, quality systems, and reporting. As a result, devices may be delayed, blocked from the market, or recalled, and manufacturers may suffer legal penalties and reputational harm.</p><p><br></p><p>In this RQM+ Live! panel discussion, experts from BSI, Brabners, and RQM+ map how sectoral, horizontal, and national requirements fit together, how notified bodies assess them, and how to build an evidence-based path to EU market access.</p><p><br></p><p>We cover practical implications of recent and emerging regulations, including:</p><ul><li>Batteries Regulation (EU) 2023/1542</li><li>AI Act (EU) 2024/1689</li><li>Packaging and Packaging Waste Regulation (EU) 2025/40</li><li>European Health Data Space Regulation (EU) 2025/327</li></ul><p><br></p><p>You’ll learn:</p><ul><li>About the market surveillance regulation (EU) 2019/1020 and EU Blue Guide.</li><li>How to identify all applicable legislation for your product and verify coverage.</li><li>What notified bodies expect to see and the typical level of scrutiny.</li><li>How to structure your compliance register, QMS updates, and regulatory reporting.</li><li>Transition timelines and planning tactics to avoid last-minute surprises.</li></ul><p><br></p><p>Who should listen: Regulatory, quality, clinical, legal, and product leaders responsible for EU market access for medical devices and IVDs.</p><p>Panelists and moderator:</p><ul><li>Greg Griffin, PhD, MRSE – Technical Specialist, BSI</li><li>Claire Burrows – Regulatory Partner, Brabners</li><li>Chris Parr, PMP – Principal, RQM+</li><li>Jaishankar Kutty, PhD – Vice President of Regulatory Affairs, Reimbursement, &amp; Market Access, RQM+ (Moderator)</li></ul><p>--</p><p>📲<a href="https://www.linkedin.com/company/rqmplus/">⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Follow RQM+ on LinkedIn.⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠</a></p><p>💼<a href="https://www.rqmplus.com/careers#open-positions">⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Check out our open positions.⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠</a></p><p>📚<a href="https://www.rqmplus.com/expert-content">⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠See free on-demand content.⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠</a></p><p>📝 If you&#39;d like to speak with us directly about how we might be able to support you and your organization, you&#39;re welcome to use <a href="https://www.rqmplus.com/book-consultation">⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠our contact form⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠</a>.</p>