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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 ePRO Can Help Comply with EU MDR Post-Market Surveillance

December 5, 2022
The EU MDR places more focus on Post-Market Surveillance (PMS) and clinical data collection. Since the EU MDR came into force, medical device manufacturers need to keep... Read More
Product Development

Tracking Serious Adverse Events for Medical Devices (to Ensure GCP Compliance)

November 24, 2022
Paragraph 64 of the European Medical Device Regulations ((EU) 2017/745 Regulation on Medical Devices) states that clinical investigations should follow “well-established... Read More
Product Development

How Does the EU GDPR Impact Medical Device Clinical Trials?

November 17, 2022
Mid 2018, most inboxes were flooded with updates on new privacy policies and data processing agreements. All credit went to the newly applicable European Union (EU) General... Read More
Product Development

8 Tips Before Calculating Sample Size in Medical Device Clinical Studies

November 11, 2022
Sample size calculation is important, not only because of industry regulations, but also because of ethical considerations. In this blog, I am going to highlight the... Read More
Product Development

MDCG Guidance Documents Overview on Clinical Investigations and Evaluations

November 3, 2022
The EU Medical Device Coordination Group (MDCG) has provided a series of guidance documents for manufacturers to use on their path to MDR compliance. In April 2020, the... Read More
Product Development

Why Investigator Initiated Studies Alone Are Not the Solution for PMCF Under EU MDR

October 27, 2022
The European Medical Device Regulation (EU MDR) requires medical device manufacturers to engage in post-market surveillance by establishing and implementing both a... Read More
Product Development

10 Best Practices for eCRF in Medical Device Trials

October 20, 2022
Transitioning from paper-based data capture to electronic case report forms (eCRF) improves the quality of data collection, lowers costs, and improves the overall efficiency... Read More
Product Development

Guidance on How to Conduct Clinical Investigations Under EU MDR

October 13, 2022
The Questions and Answers guidance document from the European Commission's Medical Device Coordination Group (MDCG) provides answers to some of the outstanding questions for... Read More
Product Development

Generate MDR Compliant Clinical Data with Investigator-Initiated Studies

October 6, 2022
The number of Investigator-Initiated Studies (IIS’s) conducted globally is on the rise. Independent patient-focused clinical studies led by physicians play an integral role... Read More

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