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About the Author

Chris is a biomedical engineer and has been in the medical device space for about 13 years. He spent a number of years managing clinical studies for Class III devices in Pivotal studies, PMA studies, and post-market registries. He is currently working as a Solutions Engineer at Greenlight Guru where he showcases the value of our Clinical Data Capture software to prospects.

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Post-Market Surveillance

How to Carry Out PMCF Activities According to EU MDR

June 11, 2024
The Post-Market Clinical Follow-up (PMCF) is a crucial part of the post-market surveillance requirements outlined in EU MDR. The goal of the PMCF is to continuously gather... Read More
Clinical Data Collection

MDCG 2024-5: Guidance on the Investigator’s Brochure Explained

May 27, 2024
The Medical Device Coordination Group (MDCG) 2024-5 document provides guidance on the content of the Investigator's Brochure (IB) for clinical investigations of medical... Read More
Clinical Data Collection

MDCG 2024-3: What the Latest Guidance on Clinical Investigation Plans (CIP) Tells Us

April 30, 2024
A clinical investigation plan (CIP) is the document in which the investigation’s sponsor will lay out the rationale, objectives, design, conduct, record-keeping and analysis... Read More

Ultimate Guide to Clinical Data Management in MedTech

April 12, 2024
For many MedTech companies, especially those that manufacture high-risk devices, clinical trials are a crucial part of getting medical devices to market and keeping them... Read More
Clinical Data Collection

Meeting Timelines and Managing Budgets - Best Practices for MedTech Clinical Investigations

April 3, 2024
If there is one universal truth in MedTech clinical trials, it is that your study will take more time than you allot for it initially. Everyone, and I mean everyone,... Read More
Clinical Data Collection

Outsourcing Clinical Activities in 2024: Choosing A CRO

March 4, 2024
In Greenlight Guru’s 2024 State of the MedTech Industry Report, 70% of respondents told us they were going to outsource at least some of their clinical activities to a... Read More
Post-Market Surveillance

Investigator Initiated Studies — 3 Common Problems and How to Fix Them

February 22, 2024
An investigator initiated study (IIS) is a clinical trial of a device that is sponsored by an independent researcher, rather than the manufacturer of the device. The clinical... Read More
Post-Market Surveillance

How to Comply with HIPAA and EU GDPR in Medical Device Studies

August 17, 2023
The U.N. recognizes privacy as a fundamental human right, and nowhere is this more important than in medical data. That’s why both the US and the EU have regulations in place... Read More

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