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

How SimplicityMD Is Leveraging Technology Plus a Lean Approach to Help Get Their Devices to Market Faster

By Nick Tippmann on March 29, 2017

In today’s episode we continue our series on new breed medical device company stories. We talk with ...

An Overview of What Device Makers Need to Know About CAPA

By Nick Tippmann on March 15, 2017

Today we will be talking about a topic that seems to be an area of continual concern and, in some ca...

How Surgical Innovation Associates Found the Benefit of Quality Beyond Just Compliance

By Nick Tippmann on March 2, 2017

At greenlight.guru, we would like to continue our series on the new breed of medical device companie...

Significant Risk vs. Nonsignificant Risk Devices - What's the Difference?

By Nick Tippmann on February 14, 2017

Do you understand the difference between significant risk and nonsignificant risk when it comes to t...

What Devicemakers Need to Know About Medical Device Reporting (MDR)

By Nick Tippmann on January 25, 2017

Medical device reporting, or MDR: what is it? What isn’t it? Why is it important?

How Phagenesis Is Developing a Treatment for Dysphagia with Rebecca Sheridan

By Nick Tippmann on January 12, 2017

What if regulatory affairs were not only viewed as a necessary burden, but actually help a medical d...

2016 Medical Device Regulatory Trends Year in Review

By Nick Tippmann on December 29, 2016

We’re in the last days of 2016, and it’s a good time to look back as we plan for the future. On toda...

Top 10 Most Popular Medical Device Articles of 2016 from greenlight guru (Plus Top 5 Free Webinars and Podcasts) - Featured Image

Using the Bucket Method for Medical Device Risk Management

By Nick Tippmann on December 6, 2016

Risk management: It’s a topic that needs to be navigated carefully by medical device companies. It’s...

Tips for Success When It Comes to IEC 60601 with Leo Eisner

By Nick Tippmann on November 22, 2016

IEC 60601 is a challenge for companies that are developing electronic medical devices. It’s wise t...

How a New Breed of Medical Device Companies Is Leveraging Technology to Get More Done with Less Resources

By Nick Tippmann on November 8, 2016

Zebra Medical Technologies is part of a new breed of medical device companies. They understand the r...

Understanding the New FDA Guidance on Changes to a 510(k)

By Nick Tippmann on October 26, 2016

What happens you need to make a change to a device that’s been cleared via 510(k)?

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