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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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Ultimate Guide to ISO 14155:2020 for Medical Devices

September 15, 2023
Clinical investigations play an important role in your journey of bringing a medical device to market. While they are often perceived as difficult and complex, having a good... Read More
Post-Market Surveillance

Alternatives to PMCF Clinical Investigations

June 15, 2023
Post-Market Clinical Follow-up (PMCF) is necessary for maintaining medical device regulatory compliance in the EU. PMCF Studies are commonly mentioned throughout the EU MDR... Read More
Clinical Data Collection

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
Post-Market Surveillance

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
Post-Market Surveillance

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
Clinical Data Collection

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
Clinical Data Collection

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
Clinical Data Collection

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
Clinical Data Collection

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

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