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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
Establishing a QMS

Guide to Managing Your Medical Device on the Market and Scaling Manufacturing

January 3, 2024
Getting a medical device to market is a huge accomplishment for any MedTech company. Design and development, regulatory approval, supplier management and manufacturing,... Read More
Post-Market Surveillance

Electronic Data Capture (EDC) Buyer’s Guide: Making the Business Case for a New EDC System

December 6, 2023
Whether you’ve got a new clinical trial on the horizon, or you’re just fed up with the limitations of the way you’re currently capturing clinical data, you’ve probably got a... Read More
Establishing a QMS

CAPA Process: Step-by-Step Instructions [+ Free Infographic]

November 3, 2023
The CAPA process is a frequent topic of discussion here at Greenlight Guru, mainly because it’s still such a big issue for medical device companies. Year after year, CAPA... Read More
Product Development

Ultimate Internal Audit Checklist: FDA QSR & ISO 13485 Audit Checklist

October 25, 2023
It was nothing more than a checklist that saved $175 million and 1,500 lives. Read More
Establishing a QMS

IVDR for In Vitro Diagnostic Medical Device Companies - Ultimate Guide

October 20, 2023
The global medical device industry is a space where forward thinking meets problem solving, all for the same purpose: to improve the quality of life. However, if you’re going... Read More
Establishing a QMS

Ultimate Guide to Corrective and Preventive Action (CAPA) for Medical Devices

October 17, 2023
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Product Development

Introducing The Greenlight Guru MedTech Suite: A Comprehensive Set Of Industry-Specific Solutions

September 18, 2023
Across the globe, visionaries and innovators are building the future of medical devices that improve the quality of life for millions of people. Read More
Product Development

How To Approach Supplier Corrective Action Requests (SCAR)

September 15, 2023
For medical device manufacturers, finding success means setting ourselves up for success with repeatable processes that not only ensure quality, but also mitigate future risk. Read More

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