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Regulatory Submission

Exploring Breakthrough Device Designation

August 25, 2023
In this episode of the Global Medical Device Podcast, Etienne Nichols and Ellie Reynolds explore FDA's Breakthrough Device designation. 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
MedTech Lifecycle Excellence

Regulatory Strategy and the Advantage of Diversity in MedTech

August 17, 2023
In this episode of the Global Medical Device podcast, we discuss the intricate world of medical device regulations, design, and innovation. Read More
Post-Market Surveillance

How to Comply with HIPAA and EU GDPR in Medical Device Studies

August 17, 2023
The U.N. recognizes privacy as a fundamental human right, and nowhere is this more important than in medical data. That’s why both the US and the EU have regulations in place... Read More
MedTech Lifecycle Excellence

Greenlight Guru Invests in State-of-the-Art Arena and Training Facility That Aims to Help Youth Basketball Players On and Off the Court

August 15, 2023
The software company is making a significant charitable investment to improve the quality of life for young athletes. 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
MedTech Lifecycle Excellence

28 Days To Save The World - True Quality Roadshow

August 10, 2023
During the Houston leg of our True Quality Roadshow series, we had the opportunity to sit down with Dan Purvis, CEO of Velentium and author of "28 Days to Save The World." Read More

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