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Data collection and management designed for MedTech clinical trials.

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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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Product Development

Understanding the 5 Phases of Medical Device Development

Adnan Ashfaq
January 20, 2023
The purpose of any medical device is to benefit others and improve the quality of life. However, in order to keep patient and user risk at a minimum, authorities have... Read More
Product Development

3 Types of QMS Audits (Plus 3 Tips to Prepare for Them)

Sara Adams
January 15, 2023
The purpose of a QMS audit is to ensure your company has established the appropriate processes and procedures within your quality management system (QMS), and that those... Read More
Product Development

Explaining the Role of PRRC under MDR & IVDR: Your Questions Answered

Etienne Nichols
January 15, 2023
There are plenty of new requirements to be aware of in both the EU Medical Device Regulation (EU MDR) and the EU In Vitro Diagnostic Device Regulation (EU IVDR). Read More
Product Development

What is an ISO Audit?

Sara Adams
January 3, 2023
When it comes to medical devices, compliance isn’t based on the honor system. Depending on where you intend to sell your device, you’ll undergo an ISO audit or inspection of... Read More
Product Development

The Best of Jon & Mike Through the Years

Etienne Nichols
December 28, 2022
Today’s episode is a little different than usual. This will be Jon Speer’s last podcast for Greenlight Guru, as he’ll be moving on to future ventures as of December 31st. Read More
Product Development

How to Verify and Validate SaMD in Different Stages

Roland Shum
December 26, 2022
Over the past decade, interest in innovating and commercializing medical devices has significantly increased. Read More
Product Development

Most Popular Medical Device Content in 2022

Greenlight Guru
December 25, 2022
“One heartbeat led us here.” Throughout 2022, this has been our signature rallying cry. Sure, it’s got a nice ring to it, and it doesn’t look too bad on a t-shirt either. But... Read More
Product Development

CDRH Proposed Guidance for FY 2023

Etienne Nichols
December 21, 2022
What are the proposed CRDH guidelines for the 2023 fiscal year, and why do they matter? How should you be thinking about them? Read More
Product Development

Design Controls Need to Start With User Needs

Jon Speer
December 19, 2022
In the FDA’s classic design control waterfall diagram, the box at the left-hand top of the waterfall is labeled “user needs.” Read More

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