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Data collection and management designed for MedTech clinical trials.

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Electronic Data Capture (EDC) Electronic Case Report Forms (eCRF) Electronic Patient Reported Outcomes (ePRO) Ad-Hoc Data Collection (Cases) Post-Market Surveys Product Add-Ons

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Posts by Chris Rush

Get the latest updates and best practices in the MedTech industry from our blog. Join 200,000+ other MedTech professionals outperforming their peers.
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Chris Rush
April 12, 2024

Ultimate Guide to Clinical Data Management in MedTech

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Establishing a QMS

FDA Publishes Final Rule on QMSR

Etienne Nichols
February 2, 2024
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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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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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Clinical Data Collection

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

Chris Rush
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
featured

Ultimate Guide to Clinical Data Management in MedTech

Chris Rush
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

Chris Rush
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

Chris Rush
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

Chris Rush
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

Chris Rush
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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