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Discover the new trends, outlooks, challenges, and opportunities in the MedTech industry in 2023.

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Greenlight Guru Medical Device Blog

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
Brittani Smith
February 26, 2023

Ultimate Guide to Postmarket Surveillance of Medical Devices

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Regulatory Submission

FDA 510(k) Submission: A Step-By-Step Guide On How To Prepare Yours

Jesseca Lyons
October 4, 2022
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Post-Market Surveillance

Selecting The Ideal PMCF Activity

Jon Bergsteinsson
July 17, 2022
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Product Development

Does My Device Labeling Comply with 21 CFR 801?

Etienne Nichols
February 28, 2023
Medical device labeling is a core requirement for getting your device onto the market. 21 CFR 801 covers general device labeling and the use of symbols. One thing the... Read More
Product Development

How to Switch from Paper to EDC Systems in Your Next Clinical Study

Jon Bergsteinsson
February 27, 2023
Clinical trials are a crucial aspect of the medical device industry, as they are used to test and validate the safety and efficacy of new treatments and devices. However, the Read More
Establishing a QMS

Ultimate Guide to Postmarket Surveillance of Medical Devices

Brittani Smith
February 26, 2023
The pursuit of MedTech Lifecycle Excellence requires that you consider the entire lifecycle of your medical device. This includes systematic monitoring of your device after... Read More
Product Development

7 Essential Steps of a Nonconformance Report

Etienne Nichols
February 24, 2023
Nonconformance is a word no quality manager wants to hear. Read More
Product Development

How to Choose an Electronic Data Capture System to Comply with EU MDR

Páll Jóhannesson
February 24, 2023
With the changes brought by the Medical Device Regulation (MDR), there is an increasing demand for systems that can support the collection and management of clinical data.... Read More
Product Development

Switching to an Electronic Device History Record (eDHR): What Medical Device Companies Should Know

Tom Rish
February 23, 2023
Your device history record (DHR) is one of the final forms of documentation you’ll need before your product ships. That doesn’t mean it’s an afterthought, however.  Read More
MedTech Lifecycle Excellence

How Communication Affects the Outcomes of Quality Activities

Etienne Nichols
February 22, 2023
Why do quality professionals struggle with clear communication in writing? What’s the problem with jargon? These are some of the questions explored in today’s podcast. Read More
Product Development

What is a Class 1 Medical Device?

Etienne Nichols
February 22, 2023
In the US, the governing body tasked with regulating the medical device market is the Food and Drug Administration (FDA). More specifically, the Center for Devices and... Read More
Product Development

FDA Human Factors Guidance Draft: What Medical Device Manufacturers Need to Know

Etienne Nichols
February 19, 2023
On December 9, 2022, the FDA issued a new draft guidance,Content of Human Factors Information in Medical Device Marketing Submissions, which provides recommendations for the... Read More

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