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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

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

Ben Bancroft
February 1, 2024
Before you can market your product in the European Union, medical device manufacturers must undergo a conformity assessment carried out by a Notified Body (NB) in order to... Read More
Product Development

Most Popular Medical Device Content in 2023

Tory Lopez
December 15, 2023
2023 was a busy and exciting year here at Greenlight Guru. Over the past 12 months, we’ve been listening closely to our customers, innovating our products, and winning... Read More
Product Development

Top 40+ Medical Device Contract Research Organizations (CROs)

Páll Jóhannesson
December 8, 2023
In the rapidly evolving MedTech industry, companies encounter numerous challenges while striving to bring devices to market. Read More
Product Development

Ultimate Guide to Supplier Management for Medical Device Companies

Ben Bancroft
November 8, 2023
A medical device is only as good as its parts. Read More
Product Development

Ultimate Guide to Software as a Medical Device (SaMD)

Wade Schroeder
October 30, 2023
Only recently has the medical device industry began designing software-based products that have no direct relationship to hardware devices at all. Read More
Product Development

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

Etienne Nichols
October 25, 2023
It was nothing more than a checklist that saved $175 million and 1,500 lives. Read More
Product Development

IQ, OQ, PQ: A Quick Guide to Process Validation

Jesseca Lyons
October 20, 2023
What is IQ, OQ, PQ? These are the abbreviations we use in the medical device industry for the three steps of process validation: Installation Qualification (IQ), Operational... Read More
Product Development

5 Foundational Steps of a CAPA Quality Process

Etienne Nichols
October 19, 2023
I have a bold opinion: The corrective and preventive action (CAPA) process is the 2nd-most important component of your quality management system (QMS). Read More
Product Development

FDA Proposes New Rule to Regulate LDTs as IVDs: Here’s What’s at Stake

Etienne Nichols
October 13, 2023
On October 3, 2023, the Food and Drug Administration (FDA) published a proposed rule seeking to amend FDA’s regulations to bring Laboratory Developed Tests (LDTs) under the... Read More

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