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Global Medical Device Podcast

Human Factors & Risk Management: What's Needed & Why?

March 2, 2022
Don’t give up on risk management. It’s the backbone of the product development lifecycle and human factors is one of its most important activities. It serves as a tool... Read More
Medical Device Industry

The Five Themes of True Quality 2022

February 25, 2022
In the medical device world, inspiration and excitement are rarely hard to come by - you just have to know where to look.  Read More
Medical Device Industry

Greenlight Guru and Lexisnexis® Reed Tech Announce Strategic Alliance to Guide Customers to Market Faster

February 24, 2022
Greenlight Guru has teamed up with LexisNexis® Reed Tech, the leader in regulatory product data submissions to global health authorities Read More
Global Medical Device Podcast

What are the Opportunities for Improvement (OFI) for Quality?

February 23, 2022
What are the shortcomings, obstacles, and challenges when it comes to quality? Are there opportunities for improvement (OFIs) for quality? The regulatory and quality... Read More
Medical Device Industry

Survey Finds Fewer Than 3% of Pre-Market Medical Device Companies Are Very Effective at Measuring the Results of Quality Initiatives

February 17, 2022
Findings from the Greenlight Guru 2022 Medical Device industry benchmark survey reveal a need to focus on quality initiatives, gaps between processes and priorities, and more Read More
Global Medical Device Podcast

Overcoming Barriers to Receiving 510(k) Clearance: One Company's Go-to-Market Triumph

February 16, 2022
They say eyes are windows to the soul; that studying someone’s gaze can reveal their innermost emotions. But what can the eyes reveal in a neurological sense,... Read More
Medical Device Product

What is the Best Way to Structure a Risk Management File?

February 13, 2022
The medical device risk management process relies heavily on the use of documentation. Whether the activity is conducted onsite or offsite, during design or after... Read More
Medical Device Industry

How to Convince Your Boss to Send You to True Quality 2022

February 11, 2022
True Quality 2022 is a must-attend experience for medical device professionals at early-stage companies. Read More
Medical Device Product

Creating a Periodic Safety Update Report (PSUR) that Complies with MDR & IVDR

February 6, 2022
The European Union Medical Device Regulation (EU MDR) and European Union In Vitro Diagnostic Regulation (EU IVDR) represent a complete overhaul of the EU regulations for... Read More

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