Surveys can be used to collect data for PMCF. But the lack of industry experience and guidance leaves clinical teams 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?
About the hosts
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 is the Chairman of the Board of the MedTech Cluster Life-Science Innovation North Denmark and as well as being a board member of the Danish MedTech startup MOTI.