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Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
EU MDR brings high expectations on Postmarket Clinical Follow-Up (PMCF) activities and greater scrutiny on the quality and quantity of PMCF data. User feedback surveys have proven to be an efficient and cost-effective method of generating PMCF data for many device manufactures. Achieving success though is not as simple as repurposing a marketing survey. For these types of surveys, ensuring the survey is scientifically valid is the biggest challenge to MDR compliance and acceptability with notified bodies.
This webcast will provide practical solutions to leveraging user feedback surveys as PMCF activities under the EU MDR, presented by former notified body leadership and PMCF subject matter experts. It will feature device examples and case studies, including an activity to develop a survey in real time during the webcast. The program is designed to offer solutions and actionable insights that you can take back your organization and implement immediately, and to ensure the following information can be easily understood and applied:
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Recently, there have been significant changes in the requirements around human factors for medical devices. This workshop will provide practical guidance and information for:
Jai joined the RQM+ clinical team in February of 2021 after seven years at BSI where he held CE marking technical and clinical leadership roles. He presents a unique blend of expertise combining cardiovascular product development and CE marking leadership with a keen appreciation for the rapidly evolving medical device regulatory landscapes.
Among many of Jai's accomplishments in his role as Technical Team Manager at BSI, he trained and developed a structural heart team of multiple technical experts that have successfully CE marked some of the most innovative cardiovascular technologies, and he developed and regularly updated multiple internal guidance docs for BSI, focused on clinical and biological safety requirements.
At RQM+, Jai supports our clients with developing solutions to complex regulatory and clinical strategy issues. His fresh-from-the-notified body perspective brings great insights and creative approaches to our clients.
Celeste has been with RQM+ for 2 years, and has over a decade of experience in regulated industries including medical devices, pharmaceuticals, and in vitro diagnostics. She has extensive experience with clinical studies, biocompatibility, regulatory affairs, and labeling. This combination of clinical and regulatory expertise along with her entrepreneurial background and spirit, make Celeste the ideal leader for the PMS & PMCF/PMPF service line at RQM+.
Celeste is committed to creating useful processes for manufacturers that improve workflow and streamline compliance with a business-balanced approach. Celeste and her team focus on helping manufacturers develop business-balanced PMCF strategies and implementing user survey programs as a PMCF solution.
Amie Smirthwaite leads the RQM+ clinical team. She is a clinical and regulatory affairs expert with more than 25 years of postdoctoral experience in medical devices, spanning new product development, quality and regulatory systems, and clinical data evaluation. Smirthwaite has worked for medical device companies, academic institutions and notified body, BSI, where she was global head of clinical compliance for 12 years. She developed BSI’s clinical compliance team and led clinical aspects of successful EU Medical Device Regulation (MDR) designation. She was also a recent contributor to European Commission Clinical Investigations and Evaluations Expert Group, including subgroups that authored guides for manufacturers and notified bodies on numerous clinical aspects of MDR compliance, as well as the soon-to-be-released Periodic Safety Update Report guidance. Smirthwaite also contributed to development of the clinical requirements for in MedDev 2.7/1 rev 4, which are now reflected in the MDR.
RQM+ is the world's leading medical device and diagnostics focused regulatory and quality consulting firm. We deliver transformative solutions by providing an unrivaled collective expertise, fueled by passion for client success. Our experts are collaborative, laser-focused on client needs, and committed to delivering high value solutions that exceed expectations. Learn more at RQMplus.com.