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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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Post-Market Surveillance

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

Jon Bergsteinsson
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
Regulatory Submission

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

Jon Bergsteinsson
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
Post-Market Surveillance

How to Collect PMCF Data for Lower-Class Medical Devices and WETs

Jon Bergsteinsson
January 26, 2023
Post-Market Clinical Follow-up (PMCF) is necessary for maintaining medical device regulatory compliance, and with the EU MDR, clinicians increasingly need to collect PMCF... Read More
Regulatory Submission

Medical Device Clinical Trials: Regulatory Pathways & Study Types Explained

Jon Bergsteinsson
January 1, 2023
In both the US and the EU, medical devices may be required to undergo a clinical trial before they can be placed on the market. A clinical trial is a systematic assessment of... Read More
Post-Market Surveillance

5 Steps For Effective Trial Design and Improved Compliance

Jon Bergsteinsson
December 29, 2022
This blog post will address a number of elements which are important for overcoming some of the challenges faced in clinical trials – whether it’s pharmaceutical, medical... Read More
Post-Market Surveillance

Randomization in Medical Device Clinical Trials: Everything You Need to Know

Jon Bergsteinsson
December 20, 2022
The purpose of MedTech clinical investigations is to gain insights about the safety and effectiveness of a medical device. To ensure the quality of those insights, clinical... Read More
Post-Market Surveillance

How ePRO Can Help Comply with EU MDR Post-Market Surveillance

Jon Bergsteinsson
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
Regulatory Submission

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

Jon Bergsteinsson
November 24, 2022
Paragraph 64 of the European Medical Device Regulations (Regulation (EU) 2017/745) states that clinical investigations should follow “well-established international guidance... Read More
Post-Market Surveillance

How Does the EU GDPR Impact Medical Device Clinical Trials?

Jon Bergsteinsson
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

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