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

7 FDA Pathways to Bring Your Medical Device to Market

By Tom Rish on February 16, 2020

Anyone reading this who is planning to launch a medical device in the U.S. has likely heard of the 5...

Understanding Post-Market Surveillance Requirements for Medical Devices (US & EU Markets)

By Taylor Brown on February 9, 2020

As leaders of medical device companies, our goal is always to create devices that are safe and effec...

2 Key Areas Missing from FDA CDRH's Regulatory Science Priorities for 2020

By Nick Tippmann on January 29, 2020

What top priorities can medical device professionals and patients expect in 2020 from the Center for...

4 Major Reasons to Use Document Version Control Software for your Medical Device

By Taylor Brown on January 26, 2020

With the incredible volume of documentation required by the FDA and ISO, using a document control sy...

7 Tips to Comply With FDA 21 CFR Part 11

By Jon Speer on January 15, 2020

When it comes to regulatory compliance for medical device companies, there can be some confusion aro...

Medical Device Classification Guide - How To Determine Your Device Class

By Tom Rish on January 2, 2020

What I am about to share with you is a guide to medical device regulatory classification.

Navigating the Twists and Turns of Change Management for Medical Devices

By Nick Tippmann on December 28, 2019

Change is constant… Especially in the medical device industry. Medical device change management can ...

What Is FDA's ASCA Pilot Program And How Does It Impact Medical Device Manufacturers?

By Nick Tippmann on December 18, 2019

FDA announced the anticipated 2020 launch of a new pilot program known as the Accreditation Scheme f...

8 Most Common Mistakes to Avoid with FDA 21 CFR Part 820

By Jon Speer on November 27, 2019

If you’re a medical device company selling or planning to sell into the US market, you should be fam...

FDA is Expanding its Case for Quality Program... Should Your Company Participate?

By Nick Tippmann on November 20, 2019

Depending on the level of quality and compliance, medical devices can impact patients’ lives for bet...

How FDA Distinguishes Between Clearance vs. Approval vs. Granted

By Tom Rish on November 3, 2019

As a medical device professional, you are well aware of how much time and effort goes into getting y...

Why the FDA Pre-Submission is an Underutilized Tool

By Jon Speer on August 25, 2019

“I wish there was a way for the FDA to give me a feedback about my medical device, prior to submissi...

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