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

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?

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...

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...

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)?

What Devicemakers Need to Know about the FDA Pre-submission Process (Part Two)

By Nick Tippmann on October 19, 2016

FDA Pre-submissions: They're a hot, timely topic.

Tips for Avoiding Problems with the First-In-Human Study Process

By Nick Tippmann on October 4, 2016

When it comes to moving from the conceptual phase of developing a medical device and actually doing ...

How to Properly Use the FDA Pre-Submission Process and Why It's So Important

By Nick Tippmann on August 31, 2016

In order to get your medical device to market, you will need to know about pre-submissions and the p...

Insights Into the New FDA 3D Printing Guidance & How It Impacts Med Device New Product Development

By Nick Tippmann on July 28, 2016

3D printing can impact new product development and manufacturing. It’s a technology that is hot in m...

Dirty Devices and Reprocessing: Are New Design Change Rules On the Horizon?

By Nick Tippmann on June 1, 2016

As medical device developers, it is our responsibilities to make sure that our products are safe and...

What Device Makers Need to Know About Design Verification and Validation with Mike Drues

By Nick Tippmann on May 10, 2016

Here’s a question for our listeners: When it comes to making sure your medical devices are safe and ...

The Difference Between Intended Use and Indications of Use (And Why These Statements Are So Important)

By Nick Tippmann on April 19, 2016

It’s time to break down the how and why of intended use and indications of use statements for your n...

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