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

30/60/90 Day Plan to Making an Impact as a Product Development Engineer

By Etienne Nichols on April 8, 2022

To say product development engineers are important to medical device development would be the unders...

Let The Document Tell The Story: Document Management Best Practices

By Etienne Nichols on March 11, 2022

Good stories follow a 3-act structure: Act 1: Set up Act 2: Conflict Act 3: Resolution “Thanks a lot...

Switching to an Electronic Device History Record (eDHR): What Medical Device Companies Should Know

By Tom Rish on December 21, 2021

Your device history record (DHR) is one of the final forms of documentation you’ll need before your ...

Engineering Change Order: The Role it Plays in the Change Management Process

By Jesseca Lyons on November 21, 2021

Change is just part of life for medical device companies. No device makes it to market without quite...

7 Documentation Musts for All Software Device Premarket Submissions

By Wade Schroeder on August 8, 2021

As the prevalence of software in medical devices and software as medical devices (SaMD) has increase...

5 Actionable Lessons Learned from the RADx Initiative by NIH

By Nick Tippmann on January 27, 2021

Rapid Acceleration of Diagnostics (RADx) is an initiative launched by the National Institutes of Hea...

Understanding and Handling Different Types of Feedback

By Nick Tippmann on January 14, 2021

What’s the relationship between product feedback, complaints, and adverse events?

6 Benefits of the Best 21 CFR Part 11 Compliant Software

By Jon Speer on December 13, 2020

Nearly every medical device company is subject to software validation requirements, regardless of wh...

Why SaMD Companies Should be Leveraging Pre-Submissions to FDA

By Nick Tippmann on December 2, 2020

Software as a Medical Device (SaMD) is one of the fastest growing segments of the medical device ind...

3 Reasons Why Closed-Loop Traceability is a QMS Must

By Jon Speer on September 27, 2020

There is a growing expectation in the medical device industry of manufacturers to demonstrate closed...

Quality Assurance vs. Quality Control in the Medical Device Industry

By Jon Speer on September 6, 2020

Imagine that your medical device malfunctioned during patient use. Do you know whether quality assur...

519 Medical Device Manufacturers Reveal Biggest Barriers to Process Improvement

By Jon Speer on August 30, 2020

In the medical device industry, there’s a lot outside of our control. The market shifts. New, innova...

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