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The process of bringing new medical devices to market is proving more prohibitive than ever before. Clinical evaluation is one of the biggest regulatory challenges early stage MedTech companies face, and having quality clinical evidence is crucial for both market access and funding. We are launching the Future Stars of MedTech program to help these companies removing the dilemma of having to choose between their budgets and high-quality clinical data
Páll Jóhannesson CEO SMART-TRIAL
A PMCF survey under the MDR is not like a traditional marketing survey and as a sponsor, you need to ensure that your methods and data will pass the scrutiny of the Notified Bodies
Jon I. Bergsteinsson, VP of Business Development, SMART-TRIAL
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
Jón I. Bergsteinsson, VP of Global Business Development, SMART-TRIAL
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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

SMART-TRIAL is Looking for the Future Stars of MedTech

SMART-TRIAL announces the Future Stars of MedTech program to help early stage MedTech companies with clinical data collection and regulatory compliance. The program will equip participating companies with clinical data collection tools, professional services,  networking and discount schemes to facilitate their clinical and regulatory pathway. The aim of the program is to level the playing field by giving the early stage innovators access to the same resources as their more established peers.With heightened requirements on post-market activities and clinical data under the EU Medical Device

SMART-TRIAL uplifting study safety reporting for MedTech

New SMART-TRIAL Adverse Event reporting capabilities helps medical device companies comply with international standards and regulations on safety reporting in clinical studiesAalborg, August 17, 2020 SMART-TRIAL has deployed a new global release of its software to enable MedTech clinical teams to comply with international standards on Adverse Event (AE) Reporting, such as the  ISO14155 and the Medical Device Regulation. This move is the first by any Electronic Data Capture vendor to provide in-built functionality directly tackling  compliance requirements set forth by regulations and

SMART-TRIAL champion surveys for medical device regulation at virtual conference

VP of Business Development for SMART-TRIAL, Jon I. Bergsteinsson set to speak on surveys for data collection to navigate Medical Device Regulation (MDR) at the first Medical Device Trials: A Virtual Experience Conference.Jon I. Bergsteinsson is set to speak on July 16th at 10 am BST on how to successfully conduct Post-Market Clinical Follow-up (PMCF) Surveys. He has covered the topic of PMCF and Surveys for MDR compliance on multiple occasions. This combined with his experience of assisting MedTech companies set up surveys in SMART-TRIAL gives him insights on both a practical and regulatory

SMART-TRIAL provides Medtech with answers to the Medical Device Regulation

A unique opportunity to gain insights on how Surveys can help fulfil the requirements on Post-Market Clinical Follow-Up (PMCF) under the new EU Medical Device Regulation (MDR)Clinical Data Experts SMART-TRIAL 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

University of Iceland uses SMART-TRIAL and eConsent to uncover the impacts of COVID-19 on a modern society

A large COVID-19 research project uses SMART-TRIAL to gather data on Iceland's  wellbeing during the Coronavirus pandemicThe COVID-19 Resilience COHORT is a one-of-a-kind study on the impact of the COVID-19 pandemic on the health and well-being of Icelanders. The novel virus has impacted many lives and this project aims to understand people’s behaviours and their physical and mental health during the pandemic.The project Resilience cohort  is undertaken by scientists at the Center of Public Health Sciences at the University of Iceland, in collaboration

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