SMART-TRIAL helps MedTech clinical teams to determine the appropriate sample size for PMCF studies

November 23, 2020

Jón Ingi Bergsteinsson, a MedTech expert and co-founder of SMART-TRIAL, will be speaking at this year's Virtual Conference on Clinical Studies with Medical Devices and IVDs on November 24th 3:05PM . Having witnessed the many pitfalls in MedTech’s data collection, Jón wants to shed light on how to successfully determine the appropriate sample size for post-market studies. Subsequently, Jon participates in a LiveQ&A session from 3:35PM to 3:45PM.

“With the date of application for the MDR approaching fast, many are struggling to design a PMCF plan to pass the scrutiny of Notified Bodies. Because of the lack of guidance and experience on PMCF, determining design choices of aPMCF study, such as the sample size, can be a challenge. ”, says Jón Ingi Bergsteinsson.

This session will highlight:

  • The importance of sample size justification for your PMCF plan
  • What determines a study sample size
  • The basics of calculating an appropriate sample size

Register for the virtual conference, which will take place on November 23rd to November 24th 2020, by visiting the conference website here:

About Jón

Jón Ingi Bergsteinsson, M.Sc. in Biomedical Engineering, is the VP of Global Business Development at SMART-TRIAL, where he helps MedTech companies to bridge the gap between their devices and clinical data.As the co-founder of SMART-TRIAL he previously served as the CTO from 2013 to 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 trials, data management, and medical devices, Jón is mostly occupied with sharing valuable insights and know-how on clinical data collection with the MedTech industry. 


SMART-TRIAL is helping MedTech clinical teams to comply with regulations on clinical evidence, by simplifying the collection and management of data. Tailor-made for MedTech, SMART-TRIAL offers ado-it-yourself Electronic Data Capture for clinical investigations and PMCF.SMART-TRIAL is built to empower clinical teams to be their best, and in full control of their data, without compromising on features, design, or compliance.Find out more on – Made for Medical Device.

For more information contact PR manager at SMART-TRIAL via