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

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.

Preparing for the Changes to the EU Medical Device and In-Virto Diagnostics Regulations

By Nick Tippmann on October 12, 2016

Agreement was reached on the eagerly awaited new EU Medical Device Regulations (MDR) and In-Vitro Di...

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 ...

Tips & Pointers for Effective Internal Quality Audits with Kyle Rose

By Nick Tippmann on September 12, 2016

Internal audits might be inconvenient and a bit nerve-wracking, but they’re also educational.

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...

greenlight guru Invited to Host Two Workshop Sessions at RAPS Convergence San Jose 2016

By Nick Tippmann on August 17, 2016

Be sure to come out and meet some of the Greenlight Guru team at the RAPS Convergence in San Jose Se...

Insider Tips and Best Practices Regarding the 510(k) Submission Process with Allison Komiyama, a Former FDA Reviewer

By Nick Tippmann on August 11, 2016

One important piece of documentation that medical device companies rely on to get them through the r...

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...

Recovery Force Accelerates Their Product Development Efforts Using greenlight guru [Case Study]

By Nick Tippmann on June 22, 2016

With its innovative technology in the highly competitive and expanding compression therapy market, i...

Preparing Your Class II Device for the UDI Compliance Deadline with Reed Tech’s Gary Saner

By Nick Tippmann on June 14, 2016

If you are part of an organization developing or producing Class II medical devices, you should know...

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...

Tips to Help You Prepare for an FDA Inspection

By Nick Tippmann on May 23, 2016

On today’s episode, we’re introducing the newest addition to the Greenlight Guru team, Jesseca Lyons...

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