SMART-TRIAL's co-founder clears up myths about the GDPR to help MedTech companies with new MDR compliance
Jon I. Bergsteinsson, a MedTech expert and co-founder of SMART-TRIAL, will be debunking myths about the EU General Data Protection Regulation (GDPR) and Medical Device Clinical Trials at this year's MedTech Summit. Jon will present a new talk called “Common Pitfalls in Medical Device Studies - How to Mitigate and Prevent Them” which will be streamed live on Wednesday the 14th of October as a part of the Clinical Evaluations and Investigations conference stream.
With 7 years of experience helping MedTech companies with clinical data collection, Jon has observed several pitfalls repeatedly in clinical trials. One of the most impactful pitfalls that MedTech companies often fall into is the wrongful adoption of the GDPR requirements for clinical trials data collection. This has resulted in companies missing out on clinical evidence, especially patient reported outcomes, which can be vital in the transition towards EU Medical Device Regulation (MDR) compliance. To turn this around, Jon will debunk these misconceptions and provide advice on how to collect personal identifiable patient data while also complying with the GDPR.
“While the EU MDR is placing more pressure on clinical teams to deliver quality evidence, companies are striving to keep expenses down. To maximise resources and overcome new challenges brought on by these new regulatory requirements, we need to help MedTech companies eliminate common issues that can hinder a successful transition towards compliance.” says Jon Bergsteinsson, VP of Global Business Development at SMART-TRIAL.
The MedTech summit is one of the most popular MedTech conferences in Europe, with over 500 delegates showing up every year. This year however is different, and like many other conferences, the MedTech Summit is a fully digital experience which will be streaming talks live all week from the 12th to the 16th of October.
To join the 2020 MedTech summit go to https://informaconnect.com/medtech-summit/
PR manager at SMART-TRIAL via marketing@smart-trial.com
About Jon I. BergsteinssonJón I. Bergsteinsson, M.Sc. in Biomedical Engineer 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 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 research, data management, and medical devices, Jón is mostly occupied with sharing valuable insights and know-how on clinical data management with the MedTech industry.
About SMART-TRIAL
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 a do-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 www.smart-trial.com – Made for Medical Devices
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