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About the Author

Páll Jóhannesson, M.Sc. in Medical Market Access, is the founder and Managing Director of Greenlight Guru Clinical (formerly SMART-TRIAL). Páll was previously the CEO of Greenlight Guru Clinical where he led the team to create the only EDC specifically made for medical devices.

Post-Market Surveillance

Boost Efficiency and Decision-Making with Enhanced Clinical Data Reporting

August 4, 2023
The latest Greenlight Guru Clinical update includes a newly designed Reporting module that streamlines clinical data management for scaling medical device companies. By... Read More
Regulatory Submission

5 Tips for Designing a Medical Device Study Under FDA Requirements

May 26, 2023
Let’s face it—medical device clinical studies are no walk in the park. There are so many variables to consider, such as patient recruitment, study design, and regulatory... Read More
Post-Market Surveillance

How to use the Greenlight Guru Clinical AE/SAE reporting module

May 8, 2023
This blog post highlights the ready-to-use Greenlight Guru Clinical module for Adverse Events (AE) and Serious Adverse Events (SAE). Let’s dive into how the reporting module... Read More
Clinical Data Collection

Why Clinical Data Is Essential to Value-Based Healthcare

May 1, 2023
The healthcare industry in many countries is undergoing a transition. We’re moving away from a strict focus on the upfront cost of care to what’s known as “value-based”... Read More
Product Development

4 Reasons to Stop Mixing Your Clinical Data Collection Methods

April 17, 2023
They say that variety is the spice of life—but when it comes to blending clinical data collection tools, it’s more like dumping the whole spice rack in the pot. One of the... Read More
Product Development

Medical Device Adverse Event Reporting Regulations: EU vs. US

March 31, 2023
Regulatory authorities in both Europe and the United States require medical device companies to report on some adverse events (AEs) that occur during clinical investigations. Read More
Clinical Data Collection

Clinical Data Management System (CDMS) for Medical Device Clinical Trials

March 16, 2023
What is Clinical Data Management? For MedTech firms running clinical investigations on medical devices, clinical data management is the process of collecting and managing... Read More
Clinical Data Collection

Everything You Need to Know about Electronic Data Capture (EDC) Systems

March 15, 2023
The purpose of a clinical investigation (or clinical study) is to determine the safety and effectiveness of a novel treatment, such as a medical device. Biostatisticians make... Read More
Product Development

How to Choose an Electronic Data Capture System to Comply with EU MDR

February 24, 2023
With the changes brought by the Medical Device Regulation (MDR), there is an increasing demand for systems that can support the collection and management of clinical data.... Read More

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