Medical Device Quality, Regulatory and Product Development Blog | Greenlight Guru

How to Plan and Conduct an ISO 14155-Compliant Clinical Investigation

By Tom Rish on May 31, 2021

Clinical investigations play an important role in your journey of bringing a medical device to marke...

5 Biggest Mistakes to Avoid when Seeking Funding for Your Medical Device

By Tom Rish on May 23, 2021

It doesn’t matter how great your medical device concept is—you’ll need some funding to get your idea...

What is 21 CFR 812 - Investigational Device Exemption?

By Laura Court on May 21, 2021

Could your medical device qualify for an investigational device exemption (IDE)?

Top Risk Management Tools in the Medical Device Industry

By Jon Speer on May 16, 2021

The role of risk management for medical devices is not just a regulatory expectation, it’s a critica...

5 Tips to Improve your Medical Equipment Quality Assurance Activities

By Sara Adams on May 14, 2021

You’ve just finished designing what appears to be the perfect medical device. It accomplishes its pr...

Managing Business Risk as a Medical Device Company

By Nick Tippmann on May 3, 2021

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

By Nick Tippmann on April 13, 2021

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

By Nick Tippmann on April 7, 2021

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

By Nick Tippmann on April 5, 2021

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

By Nick Tippmann on March 8, 2021

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

By Nick Tippmann on February 10, 2021

Keeping a constant pulse on current medical device industry standards for risk management, like ISO ...

5 Key Principles of Total Quality Management

By Taylor Brown on January 31, 2021

It's easy to think of quality as a niche responsibility, requiring only the involvement of those wor...

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