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About the Author

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

Product Development

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
Product Development

How to use the SMART-TRIAL AE/SAE reporting module

May 8, 2023
This blog post highlights the ready-to-use SMART-TRIAL module for Adverse Events (AE) and Serious Adverse Events (SAE). Let’s dive into how the reporting module benefits... Read More
Product Development

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
Product Development

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

March 16, 2023
For MedTech firms running clinical investigations on medical devices, clinical data management is the process of collecting and managing research data to produce high-quality... 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
Product Development

How Electronic Data Capture is Transforming the MedTech Industry

February 14, 2023
Though MedTech is already among the fastest-evolving markets in the world, it doesn’t mean it couldn’t still benefit from a spark of innovation. Read More
Product Development

The Pitfalls of Using Paper and Excel for Clinical Data

February 8, 2023
Keeping track of patient data and study progress is crucial to the success of a clinical trial. However, many organizations still rely on outdated methods such as paper... Read More

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