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Project Management for Product Development of Medical Devices - Featured Image

Project Management for Product Development of Medical Devices

How should you approach project management for medical device product development ? Stop managing yo...
Assessing the Global Regulatory Landscape - Featured Image

Assessing the Global Regulatory Landscape

With medical device regulations tightening around the world, especially in Europe, it's important to...
Quality Insights from a 40+ Year Veteran of the Medical Device Industry - Featured Image

Quality Insights from a 40+ Year Veteran of the Medical Device Industry

In this episode of the Global Medical Device Podcast, Jon Speer talks to Herschel “Buzz” Peddicord, ...
When to Throw the Least Burdensome Flag on FDA - Featured Image

When to Throw the Least Burdensome Flag on FDA

What if you submit your 510(k), IDE, or other submission type to FDA only to get an additional infor...
Past, Present, Future State (and World) of Quality in the Medical Device Industry - Featured Image

Past, Present, Future State (and World) of Quality in the Medical Device Industry

Quality is a concept that is often overcomplicated in the medical device industry. With complexity c...
Focusing on the Intent of the UDI Requirements from FDA's Final Guidance Doc - Featured Image

Focusing on the Intent of the UDI Requirements from FDA's Final Guidance Doc

When the Unique Device Identification (UDI) system was first announced by FDA several years ago, the...
Addressing the 'Who, What, When' of Quality in the Medical Device Industry - Featured Image

Addressing the 'Who, What, When' of Quality in the Medical Device Industry

There are many schools of thought when it comes to the 'who, what, and when' of quality management f...
Meet a Guru: Maryann Mitchell - Featured Image

Meet a Guru: Maryann Mitchell

What makes Greenlight Guru unique and sets it apart from other medical device solutions? It’s Guru e...
Why Storytelling Matters for Medical Device Companies - Featured Image

Why Storytelling Matters for Medical Device Companies

Medical device companies need to tell slightly different versions of their stories depending on the ...
A Breakthrough Device that Aims to Prevent Osteoporosis - Featured Image

A Breakthrough Device that Aims to Prevent Osteoporosis

Is your body becoming more frail? Are you worried about fractures? Do you want to improve your bone ...
Understanding FDA's New Intended Use Rule and its Implications - Featured Image

Understanding FDA's New Intended Use Rule and its Implications

FDA published a final rule, which goes into effect the first of September, to amend its “intended us...
eQMS in Academia: Practical Learning for Biomedical Engineering Students - Featured Image

eQMS in Academia: Practical Learning for Biomedical Engineering Students

Have you ever thought about the versatility of an eQMS? As it turns out, the use of one medical devi...

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Providing you actionable tips, best practices and insights for better medical device quality, compliance and product development.

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