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Establishing a QMS

Greenlight Guru Celebrates 10 Years by Introducing its Multi-Product MedTech Suite

September 19, 2023
The software company is expanding its product offering to meet the evolving needs of the medical device industry. Read More
Product Development

Ultimate Guide to Device Class Requirements under EU MDR

September 19, 2023
Marketing a device in the European market means complying with the numerous safety and technical requirements of the Medical Device Regulation (MDR). In practice, this can be... Read More
Establishing a QMS

Greenlight Guru Yet Again Ranked as a Leader in QMS and Medical QMS Categories in G2 Fall 2023 Grid Reports

September 13, 2023
The leaves may be starting to change, but one thing you can count on staying the same is G2 ranking Greenlight Guru as a Leader in both the QMS and Medical QMS Grid® Reports. Read More
Establishing a QMS

What is a Predetermined Change Control Plan (PCCP) and Who Needs One?

September 1, 2023
In April 2023, FDA published a new draft guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning... Read More
Product Development

3 Tips for Adding Flexibility to Your MedTech Manufacturing Supply Chain

August 25, 2023
Supply chain management is crucial to any MedTech company’s ability to deliver safe, effective, and high-quality devices to their customers. Read More
Product Development

Machine Learning, AI and Risk Management: TIR34971 Explained

August 18, 2023
TIR34971:2023, Application of ISO 14971 to machine learning in artificial intelligence, was published in March 2023. Read More
Establishing a QMS

Conducting Quality Investigations in Medical Device Manufacturing

August 11, 2023
When a quality event, like a product or process nonconformance, occurs in the manufacturing of medical devices, there’s a chance that the safety and efficacy of any affected... Read More
Establishing a QMS

Omnibus Act Impact on Medical Device Cybersecurity

August 7, 2023
The ‘‘Consolidated Appropriations Act, 2023’’ (H.R. 2617) was passed by the U.S. Senate and signed into law by President Biden on December 29, 2022. Read More
Establishing a QMS

QMSR Explained: What FDA QSR & ISO 13485 Harmonization Means for Medical Device Companies

July 21, 2023
On February 23, 2022, FDA released its proposed rule for the new Quality Management System Regulation (QMSR). Read More

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