Date: 29 October 2024
Time: 4.00 - 5.00 pm CET | 3.00 - 4.00 pm GMT
Language: English
Introduction
Collecting Clinical Data through Post-Market Clinical Follow-up (PMCF) activities is an essential component in monitoring the safety and performance profile of your Medical Device under the EU MDR. However, gathering reliable post-market clinical data is complex and presents medical device manufacturers with unique challenges.
In this complimentary webinar, expert speakers will delve into proven strategies and practical solutions to help you navigate these challenges. Learn how to optimize your PMCF process, enhance data quality, and ensure regulatory compliance. Plus, take advantage of our live Q&A session, where you can engage directly with our experts to address your specific questions and concerns.
Whether you're new to PMCF or looking to refine your approach, this webinar is designed to provide actionable insights to help you achieve success in your PMCF activities. Don’t miss this opportunity to stay ahead of the curve and ensure your medical devices meet the highest standards of safety and performance.
This webinar will be co-hosted with Purdie Pascoe and BSI.
Speakers
Bianca Lutters, Head of Clinical Operations at Qserve Group. Bianca has more than 15 years of experience in the medical devices field, ten of which have been spent at two major Notified Bodies, DEKRA and BSI. In her time working for Notified Bodies, Bianca assessed many design dossiers and technical files, including (cardio)vascular devices, drug-device combinations, absorbable devices, and devices containing animal tissue. In addition, as a lead auditor, she has conducted many QMS audits, including several unannounced audits, for a wide range of manufacturers and distributors in the MedTech sector.
Marcus Torr, MDR/PMCF Lead at Purdie Pascoe. Marcus joined Purdie Pascoe in 2015 with a First Class MSci in Natural Sciences (Chemistry with Pharmacology) from the University of Bath. Since joining he has rapidly gained experience and skill in quantitative research and has led, and grown, the PMCF team at Purdie Pascoe for the last five years, who provide PMCF survey solutions to the medical device industry to ensure EU-MDR compliance. He has extensive knowledge of the specific requirements surrounding PMCF surveys, having overseen over 400 surveys for several of the leading global Medical Device manufacturers across a variety of device types. These surveys have been approved by several of the leading Notified Bodies and consist of both end-user general surveys (Level 8) and high-quality patient-specific surveys (Level 4).
Chris Webb, PMCF Manager at Purdie Pascoe. Chris joined Purdie Pascoe in 2019 with a BSc in Biochemistry and Molecular Medicine from the University of Nottingham. Since then, Chris has progressed to become a PMCF Manager. He leads on projects to assist a wide range of medical device manufacturers in the design, implementation, and analysis of PMCF surveys. Over the last 5 years Chris has gained experience in all aspects of the PMCF survey process and has worked with both high quality (level 4) and general usability surveys (level 8) over a range of device types and risk classifications.
Rachel Mead, Clinical Regulatory Lead at BSI
Rachel Mead holds an Honours degree in Electronics and Electrical Engineering from the University of Glasgow and is a member of the Institution of Engineering and Technology. Rachel began her career twenty years ago as a research scientist in industry. Since then, she has held various research and development positions in medical device companies and has experience with clinical investigations of medical devices. Joining BSI as a Technical Specialist and Scheme Manager in 2018, Rachel currently holds the position of Clinical Regulatory Lead, where she has a particular focus on the clinical evaluation of medical devices.
Qserve Speaker