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More than a Quality Management System: Tools for the entire MedTech Lifecycle.

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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 Páll Jóhannesson

Get the latest updates and best practices in the MedTech industry from our blog. Join 200,000+ other MedTech professionals outperforming their peers.
Establishing a QMS
Etienne Nichols
February 2, 2024

FDA Publishes Final Rule on QMSR

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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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Ultimate Guide to ISO 14155:2020 for Medical Devices

Jon Bergsteinsson
September 15, 2023
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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.

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Clinical Data Collection

The Essential Guide to eCRF (Electronic Case Report Form) for Medical Devices

Páll Jóhannesson
January 24, 2023
In clinical investigations, investigators traditionally use paper Case Report Forms (CRFs) to collect data from participating patients, including patient characteristics and... Read More
Clinical Data Collection

How to Plan a Clinical Data Management Setup for EDC Systems

Páll Jóhannesson
January 20, 2023
When it comes to setting up forms and questionnaires for electronic data capture (EDC) systems, we’ve noticed a trend. Most are keen to get their study started but have not... Read More
Regulatory Submission

The 3 C’s of the EU MDR: Changes, Challenges and Contributions

Páll Jóhannesson
January 12, 2023
The new European Union Medical Device Regulation (EU MDR) comes with a steep path to compliance. But it also comes with a more effective path to achieving a common goal - 'A... Read More
Clinical Data Collection

7 Key Pitfalls To Avoid In MedTech Clinical Data Collection

Páll Jóhannesson
January 6, 2023
Clinical data collection is the process in medical research and patient care that involves gathering and analyzing data generated from patient care activities and clinical... Read More
Clinical Data Collection

Optimizing Generation of Clinical Evidence for Medical Devices

Páll Jóhannesson
December 22, 2022
MEDDEV 2.7/1 revision 4, defines clinical evidence as:"The clinical data and the clinical evaluation report pertaining to a medical device." This is both a simple and valid... Read More
Clinical Data Collection

How Technology Can Support Clinical Trial Continuity & Data Integrity

Páll Jóhannesson
December 15, 2022
The Covid Pandemic impacted the way we live and work. Its impact was felt on every aspect of what we did and no industry was immune. Naturally, that means that the MedTech... Read More
Regulatory Submission

Electronic Data Capture for Medical Devices: Then vs. Now

Páll Jóhannesson
December 9, 2022
Decades ago, data from clinical trials could only be captured using paper Case Report Forms (CRFs). Researchers would fill out the CRFs by hand at the site of the clinical... Read More
Post-Market Surveillance

How to Use Greenlight Guru Clinical's ePRO Module

Páll Jóhannesson
December 9, 2022
Greenlight Guru Clinical is the only MedTech-specific electronic data capture (EDC) system. One of the first features built into our EDC system was an integrated e-mail and... Read More
Post-Market Surveillance

10 Tips for Selecting the Right EDC Software for Clinical Investigations

Páll Jóhannesson
September 29, 2022
Using Electronic Data Capture (EDC) software can save you time and money in the data collection process for your medical device clinical investigation - but how do you... Read More

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