Clinical data experts, Smart-Trial, will host an online Q&A session where medtech clinical teams are encouraged to ask questions about using surveys for Post-Market Clinical Follow-up (PMCF), to comply with the EU Medical Device Regulation (MDR).
Participants can submit their questions before and during the live event which is scheduled for the 11th June 2020 at 15:00 CEST (14:00 BST).
The live Q&A will be hosted by Jon I. Bergsteinsson, VP global business development, Smart-Trial, and Pall Johannesson, CEO, Smart-Trial, who together will provide insights on how to conduct a successful PMCF survey, and answer the audience questions.
Bergsteinsson said: “Since my webinar on PMCF back in January, I have continued to receive various questions on PMCF and even more so on surveys as a tool to collect PMCF data. It’s clear to me that the industry is looking for insights and guidance, which I will be sharing in the live Q&A session, while also taking questions from the audience.”
This live Q&A provides medtech industry professionals with a chance to get actionable insights by getting their own questions answered and converse with their peers. The focus for this PMCF Survey live Q&A session is to ‘provide answers’ to the otherwise unmet questions, and to enable teams to sufficiently prepare to comply with the new MDR date of application.
A PMCF survey under the MDR is not like a traditional survey. As a sponsor, you need to ensure that the methods and data will pass the scrutiny of the notified bodies. Due to the lack of experience and guidance on the topic, clinical teams are finding it hard to navigate and are left with open questions like:
- How can a survey comply with Annex XIV (B) of the EU MDR?
- How does GDPR impact a survey?
- How can a survey comply with ISO14155?
- How many people should I recruit (sample size)?
- How do I ensure the quality and traceability of data?
- What's the maximum number of questions to ask a clinician?
You can submit your survey questions ahead of the PMCF webinar here.