A unique opportunity to gain insights on how to use compliant clinical data software to fulfill the requirements under the new EU Medical Device Regulation for Post-Market Clinical Follow-Up .
SMART-TRIAL has announced a unique 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 of June 2020 at 15:00 CEST.
Surveys are one of the tools medical device manufacturers can use to collect data for PMCF. But 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. But 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 max no. of questions to ask a clinician?
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.
This live Q&A provides MedTech industry professionals with a chance to get actionable insights by getting their own questions answered and also derive inspiration from the questions asked by 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.
“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 us that the industry is looking for insights and guidance, which we will be sharing in the Live Q&A session, while also taking questions from the audience”Jon I. Bergsteinsson, VP Global Business Development, SMART-TRIAL.
Ask PMCF Survey questions here: https://info.smart-trial.co/liveqa/post-market-clinical-follow-up-survey
Hosts of the PMCF Survey live Q&A
Jón I. Bergsteinsson, M.Sc. Biomed. Eng. is the VP of Global Business Development and the co-founder of SMART-TRIAL, he also served as the CTO until 2017 where he paved the way for the platform’s quality standards, data security, and compliance. With a strong technical background, and 10 years of experience in clinical informatics, research, and medical devices, Jón’s primary mission is to share valuable insights and know-how on clinical data management with the MedTech industry.
Páll Jóhannesson, M.Sc. Medical Market Access is the co-founder and CEO of SMART-TRIAL. Páll has over 10 years’ of experience with the development of eClinical tools for clinical studies for medical devices. Páll is an experienced professional within health economic outcome research, clinical data management, and clinical trial design for industry and public-funded research. Páll serves as the Chairman of the Board of the MedTech Cluster Life-Science Innovation North Denmark and as well as being a board member in the Danish MedTech startup MOTI.
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Erika Michelle Pinto