Description

Please note we share the webinar recording and slides with all registrants. If you're not sure if you can attend on April 27, we encourage you to register regardless in order to receive the information.

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.

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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.

Panelists:

• Jai Kutty, Ph.D., VP of Clinical Regulatory Affairs, RQM+
• Amie Smirthwaite, Ph.D., Global VP of Clinical Services, RQM+
• Celeste Maksim, Ph.D., RAC, Service Line Leader, PMS/PMCF/PMPF Services, RQM+