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Greenlight Guru Medical Device Blog

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Managing Business Risk as a Medical Device Company - Featured Image

Managing Business Risk as a Medical Device Company

It's easy to get so wrapped up in the risk management of your medical device that you forget about m...
Pros & Cons of Being a Physician turned MedTech Inventor - Featured Image

Pros & Cons of Being a Physician turned MedTech Inventor

Do you fear needles and the associated pain? No one understands this fear more than physicians who s...
3 Systems of Risk for Medical Devices from FDA - Featured Image

3 Systems of Risk for Medical Devices from FDA

Why does FDA have three systems in place to address and handle risk for medical devices? Each system...
Quality Management for IVD Devices vs Medical Devices - Featured Image

Quality Management for IVD Devices vs Medical Devices

How are in vitro diagnostic (IVD) devices similar and different from medical devices? How should IVD...
Greenlight Guru Launches Greenlight Guru Academy as a Trusted Source of Education to the Global Medical Device Community - Featured Image

Greenlight Guru Launches Greenlight Guru Academy as a Trusted Source of Education to the Global Medical Device Community

Greenlight Guru Academy will educate and train medical device professionals on everything they need ...
Inside Look into ISO 14971:2019 & ISO TR 24971:2020 from the Author's Point of View - Featured Image

Inside Look into ISO 14971:2019 & ISO TR 24971:2020 from the Author's Point of View

Keeping a constant pulse on current medical device industry standards for risk management, like ISO ...
5 Key Principles of Total Quality Management - Featured Image

5 Key Principles of Total Quality Management

It's easy to think of quality as a niche responsibility, requiring only the involvement of those wor...
5 Actionable Lessons Learned from the RADx Initiative by NIH - Featured Image

5 Actionable Lessons Learned from the RADx Initiative by NIH

Rapid Acceleration of Diagnostics (RADx) is an initiative launched by the National Institutes of Hea...
Change Management Process Explained in 6 Easy Steps (+ free template) - Featured Image

Change Management Process Explained in 6 Easy Steps (+ free template)

In Prosci’s research, participants were six times more likely to meet project goals by following an ...
How to Assess the Impact of Any Change to your Medical Device (+ Free Checklist) - Featured Image

How to Assess the Impact of Any Change to your Medical Device (+ Free Checklist)

So you need to make a change to your medical device, what now?
Greenlight Guru and Nelson Labs Announce Strategic Alliance to Mitigate Risk and Guide Customers to Market Faster - Featured Image

Greenlight Guru and Nelson Labs Announce Strategic Alliance to Mitigate Risk and Guide Customers to Market Faster

Customers benefit from expert advice to lower development costs and save time identifying the right ...
Medical Device Biocompatibility 101 - Featured Image

Medical Device Biocompatibility 101

Medical device biocompatibility can be confusing, challenging, even frustrating for device professio...

The Greenlight Guru Medical Device Blog

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

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