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Product Development

How To Approach Supplier Corrective Action Requests (SCAR)

September 15, 2023
For medical device manufacturers, finding success means setting ourselves up for success with repeatable processes that not only ensure quality, but also mitigate future risk. Read More
Product Development

Engineering Change Order: Its Role in the Change Management Process

September 14, 2023
Change is just part of life for medical device companies. No device makes it to market without quite a few changes to its design along the way, and even devices already on... Read More
Product Development

5 Tips for Medical Device Registration across Global Markets

September 14, 2023
You have compiled all of the necessary documentation for your regulatory submission, submitted it to the appropriate regulatory body, and received the much-anticipated news... 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
Product Development

ISO 14971 Risk Management for Medical Devices: The Definitive Guide

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In April 2023, FDA published a new draft guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning...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

What is the FDA Medical Device Registration Process?

August 22, 2023
To patients and providers, medical devices are more than a product. They serve as the conduit to better quality of life for patients, improve diagnostic speed and accuracy,... 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

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