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About the Author

Jón Ingi Bergsteinsson, M.Sc. in Biomedical Engineering, is the founder and Director of EMEA Sales at SMART-TRIAL by Greenlight Guru, where he helps MedTech companies bridging the gap between their devices and clinical data. As the technical founder of SMART-TRIAL he previously served as the CTO where he paved the way for the platform’s quality standards, data security, and compliance.

Product Development

How to Plan and Budget for MedTech Clinical Activities

June 5, 2023
For years, medical device manufacturers have treated clinical data as a regulatory burden—a low-priority obligation that doesn’t garner much attention. Why? It’s primarily... Read More
Product Development

How To Use FDA’s Guidance on Post-Approval Studies During Premarket Approval

May 24, 2023
In the US, post-market clinical studies are not required of every medical device manufacturer. However, FDA does have the authority to order post-market surveillance of any... Read More
Product Development

How to Use Clinical Data in Medical Device Submissions in the EU & US

April 20, 2023
Bringing medical devices to market is still harder than it should be. Obtaining regulatory approval for medical devices is a rigorous process that involves submitting... Read More
Product Development

ePRO vs Paper: The Debate Over Patient Reported Outcomes Is Over

April 5, 2023
Patient reported outcomes (PRO) are becoming increasingly important to medical device clinical trials. Your regulatory strategy, reimbursement strategy, marketing, and more... Read More
Product Development

Electronic Data Capture Systems vs. Paper-based Data Collection

March 24, 2023
In this blog, we’ll be comparing electronic data capture (EDC) systems to paper-based data collection systems. To do so, we’ll be reviewing four independent studies: ... Read More
Product Development

Complying with Good Clinical Practice in Clinical Data Collection

March 8, 2023
For medical device manufacturers, clinical data is more than a collection of numbers and statistics—it’s a snapshot of the lives of patients you’re trying to help. And while... Read More
Product Development

Research shows eCRFs faster, more reliable than paper CRFs

March 3, 2023
The case report form (CRF) is a staple in clinical studies. These are the forms clinical investigators use to collect patient information related to an ongoing clinical... Read More
Product Development

How to Switch from Paper to EDC Systems in Your Next Clinical Study

February 27, 2023
Clinical trials are a crucial aspect of the medical device industry, as they are used to test and validate the safety and efficacy of new treatments and devices. However, the Read More
Product Development

3 Factors that Impact Application of Decentralized Clinical Investigations for Medical Devices

February 17, 2023
The COVID-19 pandemic drove a huge interest in the concept of decentralized clinical investigations. The pandemic forced many MedTech manufacturers to re-evaluate their... Read More

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