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MedTech Lifecycle Excellence Platform

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Greenlight Guru Medical Device Blog

Get the latest updates and best practices in the MedTech industry from our blog. Join 170,000+ other MedTech professionals outperforming their peers.
Establishing a QMS
Nick Tippmann
June 16, 2022

MedTech Lifecycle Excellence: Out of the Dark and into the Age of Enlightened Quality

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Establishing a QMS

Greenlight Guru Acquires Electronic Data Capture Solution SMART-TRIAL

Nick Tippmann
June 2, 2022
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Product Development

ISO 14971 Risk Management for Medical Devices: The Definitive Guide

Jon Speer
June 11, 2021
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Product Development

Preventing the Death of Medical Device Sales

Nick Tippmann
July 13, 2022
The medical device sales industry is slow to change. It’s behind on how hospitals and physicians adopt and adapt to buying, sales strategies are out of date, and... Read More
Product Development

5 Signs Your MedTech Startup is Ready for the Next Round of Funding

Etienne Nichols
July 10, 2022
Medical device startups are one of the greatest sources of inspiration in the MedTech industry. Read More
Product Development

Purpose-Built QMS vs General-Purpose QMS: What You Can Expect From Each

Etienne Nichols
July 8, 2022
Just like the tools at your local hardware store, quality management software comes in many shapes and sizes. Read More
Product Development

Shifting Sands of SaMD Cybersecurity Regulations

Nick Tippmann
July 5, 2022
FDA has issued new draft guidance on cybersecurity for software as a medical device (SaMD). If the FDA releases that draft guidance ‘as is,’ it will massively and negatively... Read More
Product Development

Understanding The Relationship Between Usability and Labeling of Your Medical Device

Etienne Nichols
July 3, 2022
Though they span a huge spectrum of applications, all medical devices are created for the same purpose: to improve the quality of life for their users. Read More
Product Development

How To Apply a Risk-Based Approach to Biological Evaluation

Laura Court
July 1, 2022
No matter where you plan on marketing your medical device, you’ll be required to perform a biological evaluation on your device before you receive regulatory approval. Read More
Product Development

Early Stage Territory Planning for Medical Device Companies

Nick Tippmann
June 29, 2022
Do your field teams still rely on map, spreadsheet, and note apps? How medical device companies have historically generated sales is no longer adequate for selling... Read More
Product Development

Selecting a Notified Body: How to Work with Your New Device Authority

Ben Bancroft
June 26, 2022
Before you can market your product in the European Union, you’ll need a CE marking for your device. And for all but the lowest risk devices (Class I), medical device... Read More
Product Development

4 Letter to File Mistakes That Could Cost You

Etienne Nichols
June 24, 2022
Innovation in medical device technology happens quickly - not only with new product designs, but also with improvements made to existing devices. Read More

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