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In this webinar we will provide practical solutions for leveraging user feedback surveys as PMCF activities under the EU MDR, presented by former notified body leadership and PMCF subject matter experts.

RQM+ has conducted many user feedback surveys for our clients at this point in MDR implementation. We've encountered combinations of devices and clinical data where this is the perfect solution for meeting PMCF requirements, and others where a lot of strategy is needed to make it work.

This webinar will provide you with the following, all with use device examples and case studies to ensure the following information can be easily understood and applied:

  • An assessment pathway for determining if user feedback surveys can be leveraged for your device.
  • An understanding of the requirements of a scientifically valid user feedback survey, and where people commonly go wrong.
  • Guidance on ensuring the surveys will meet notified body expectations around scientific validity and other requirements.
  • Definition of the practical regulatory, ethical and data privacy considerations, to ensure your data is acceptable to all regulatory authorities.
  • Actionable information helping you to chart your course to having a successful PMCF plan and data for ongoing MDR compliance and CE marking.

 


Presenters

Jai Kutty, Ph.D.
VP of Clinical Regulatory Affairs, RQM+
jai_kutty-1Jai 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.



Amie Smirthwaite, Ph.D.
Global VP of Clinical Services, RQM+
amie_smirthwaiteAmie joined RQM+ in March of 2020. A clinical and regulatory affairs expert, Dr Amie Smirthwaite has over 25 years’ postdoctoral experience in medical devices, spanning new product development, quality and regulatory systems, and clinical data evaluation. She is leading the RQM+ clinical team and brings a wealth of knowledge and experience having worked for medical device companies, academic institutions and BSI.

As former Global Head of Clinical Compliance at BSI (12 years, through March 2020), Amie developed BSI’s clinical compliance team and lead clinical aspects of successful MDR designation. She was also a recent contributor to European Commission Clinical Investigations and Evaluations Expert Group, including subgroups which authored MDCG 2019-9, MDCG 2020-5, 6, 7, 8, and 13 (SSCP, Clinical Evaluation, Sufficient clinical evidence, PMCF, and more), and the to-be-released guidance on PSUR, and contributed to development of the requirements for clinical in MedDev 2.7/1 rev 4, which are now reflected in the MDR.


Celeste Maksim, Ph.D., RAC
Service Line Leader, PMS/PMCF/PMPF Services, RQM+
celeste_square-minCeleste 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.