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Data collection and management designed for MedTech clinical trials.

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Posts by Jon Bergsteinsson

Get the latest updates and best practices in the MedTech industry from our blog. Join 200,000+ other MedTech professionals outperforming their peers.
Establishing a QMS
Etienne Nichols
February 2, 2024

FDA Publishes Final Rule on QMSR

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Establishing a QMS

Guide to Managing Your Medical Device on the Market and Scaling Manufacturing

Laura Maher
January 3, 2024
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Ultimate Guide to ISO 14155:2020 for Medical Devices

Jon Bergsteinsson
September 15, 2023
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About the Author

Jón Ingi Bergsteinsson, M.Sc. in Biomedical Engineering, is the co-founder of Greenlight Guru Clinical (formerly SMART-TRIAL). He was also the technical founder of Greenlight Guru Clinical where he paved the way for the platform’s quality standards, data security, and compliance.

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Regulatory Submission

8 Tips Before Calculating Sample Size in Medical Device Clinical Studies

Jon Bergsteinsson
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
Post-Market Surveillance

MDCG Guidance Documents Overview on Clinical Investigations and Evaluations

Jon Bergsteinsson
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
Post-Market Surveillance

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

Jon Bergsteinsson
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
Regulatory Submission

10 Best Practices for eCRF in Medical Device Trials

Jon Bergsteinsson
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
Regulatory Submission

Guidance on How to Conduct Clinical Investigations Under EU MDR

Jon Bergsteinsson
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
Regulatory Submission

Get Compliant Clinical Data with Investigator-Initiated Studies

Jon Bergsteinsson
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
Post-Market Surveillance

The Medical Device Practical Guide to PMCF Requirements under EU MDR

Jon Bergsteinsson
October 3, 2022
The European Medical Device Regulation (EU MDR) deadlines are closing in for re-certification and/or introduction of new products. Read More
Post-Market Surveillance

eCRF Template for Clinical Investigations and PMCF Studies

Jon Bergsteinsson
September 15, 2022
The key to an effective Electronic Data Capture (EDC) system setup is proper planning. If electronic Case Report Forms (eCRF) are not prepared well before setup, you can risk... Read More
Post-Market Surveillance

The Practical Guide to Post-Market Clinical Follow-up EU MDR Compliance

Jon Bergsteinsson
September 4, 2022
Everything a Medical Device Manufacturer Needs to Know About Post-Market Clinical Follow-up Read More

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