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MedTech Lifecycle Excellence

Moving MedTech Forward - The Past, Present & Future of Greenlight Guru

September 21, 2023
In this riveting episode of the Global Medical Device Podcast, Etienne Nichols brings together the dynamic leaders from Greenlight Guru: David DeRam (internally known as DD)... Read More
Establishing a QMS

Greenlight Guru Celebrates 10 Years by Introducing its Multi-Product MedTech Suite

September 19, 2023
The software company is expanding its product offering to meet the evolving needs of the medical device industry. Read More
Product Development

Ultimate Guide to Device Class Requirements under EU MDR

September 19, 2023
Marketing a device in the European market means complying with the numerous safety and technical requirements of the Medical Device Regulation (MDR). In practice, this can be... Read More

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

Ultimate Guide to ISO 14155:2020 for Medical Devices

September 15, 2023
Clinical investigations play an important role in your journey of bringing a medical device to market. While they are often perceived as difficult and complex, having a good... Read More
MedTech Lifecycle Excellence

From Academia to FDA Clearance (True Quality Roadshow - Boston)

September 14, 2023
In this episode recorded in front of a live audience in Boston, MA, we speak with Christy Sheehy-Bensinger, the CEO & Founder of C-Light Technologies, Inc. about their... Read More
Establishing a QMS

Greenlight Guru Yet Again Ranked as a Leader in QMS and Medical QMS Categories in G2 Fall 2023 Grid Reports

September 13, 2023
The leaves may be starting to change, but one thing you can count on staying the same is G2 ranking Greenlight Guru as a Leader in both the QMS and Medical QMS Grid® Reports. Read More
Post-Market Surveillance

How to Structure a Clinical Investigation Report (CIR) Summary

September 8, 2023
If you’re conducting a clinical investigation of a medical device in an EU Member State, you will be required to submit a clinical investigation report (CIR) along with a... Read More
Regulatory Submission

Accelerating SaMD Development in a Compliant Agile Way

September 7, 2023
In this episode, we explore the impact of software development methodologies in the medical device industry. Read More

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