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Establishing a QMS

Enterprise Quality Management Software: What You Need To Know

November 14, 2023
A quality management system (QMS) is simply a formalized system for documents, policies, procedures, and processes that companies in many industries—including MedTech—use to... Read More
Regulatory Submission

Recent FDA Draft Guidances

November 9, 2023
In this episode, we dissect the evolving landscape of FDA medical device regulations with regulatory expert Mike Drues. Read More
MedTech Lifecycle Excellence

The AI in MedTech Trend Report 2023 Is Here

November 7, 2023
At Greenlight Guru, when we want to know exactly what’s happening in the MedTech industry, we like to go to the source: the medical device professionals who work every day to... Read More
MedTech Lifecycle Excellence

Greenlight Guru Releases The AI in MedTech Trend Report 2023

November 7, 2023
The survey of more than 200 medical device professionals is a snapshot into the interest and attitudes toward AI tools and their adoption in the MedTech industry. Read More
Regulatory Submission

Planning an FDA Submission

November 2, 2023
In this episode, Etienne Nichols and Ellie Reynolds, Associate Director of Quality Assurance and Regulatory Affairs at Proxima Clinical Research, dive deep into the... Read More
Establishing a QMS

Benefits of Switching from MasterControl to Greenlight Guru

November 2, 2023
At Greenlight Guru, we pride ourselves on building products specifically for MedTech companies. With more than 1,100 customers worldwide, we take our mission to move MedTech... Read More
MedTech Lifecycle Excellence

Reducing Medical Device Risk with Usability Testing: The Why, the How, and the Who

November 1, 2023
Industry research shows that each year, approximately 400,000 hospitalized patients experience some kind of preventable harm. Read More
Product Development

Ultimate Guide to Software as a Medical Device (SaMD)

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
Establishing a QMS

Top 7 QMS Tools for MedTech (Plus 4 Bonus Resources)

October 27, 2023
The FDA’s Quality System Regulation (QSR) and ISO 13485:2016 both lay out requirements for a medical device manufacturer’s QMS. (The two will soon be harmonized, but that’s... Read More

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