Regulatory Tips & Strategies from a Former FDA Reviewer

By Nick Tippmann on October 10, 2018

What are some recent trends and observations in the medical device industry regarding regulatory aff...

Scaling Regulatory and Quality with Your Company

By Jon Speer on September 2, 2018

Have you thought about your systems and processes related to regulatory and quality standards?

A Step-by-Step Guide to Preparing Your FDA 510(k) Submission

By Jesseca Lyons on July 20, 2018

What's this guide all about anyways? Feeling a little lost as you start to compile your first 510(k)...

7 Questions About the European MDR Answered

By Jon Speer on July 2, 2018

The European Medical Device Regulation (MDR) is a new set of regulations that governs the production...

Debunking Premarket Approval (PMA) Myths (And Why the PMA Path May Not Be as Scary as You Think)

By Nick Tippmann on May 15, 2018

When developing a new medical device, do you try to figure out the fastest and simplest way to get y...

Sneak Peek Into the ISO 14971 Revision Process (From a Member of the Standard's Working Group, JWG1)

By Edwin Bills, ASQ Fellow, RAC on May 14, 2018

The ISO Technical Committee TC 210 Joint Working Group 1 (JWG1) is a committee that reports to not o...

The Ultimate Guide To Design Controls For Medical Device Companies

By Jon Speer on May 7, 2018

Helping to Prepare Biomedical Engineers Entering the Workforce

By Nick Tippmann on April 24, 2018

Students offer hope for our future. They will be developing products that can save our lives, or at ...

Competitive Regulatory Strategy vs. Regular Regulatory Strategy

By Jon Speer on April 23, 2018

Every medical device developer would like to take the fastest path to market, right? Sometimes the k...

Medical Device QMS Changes: How to Manage Changes Regarding EU MDR, IVDR & ISO 13485:2016

By Rod Beuzeval on January 30, 2018

One thing that seems to be constant in the global medical device industry is change.

Evaluating FDA’s “New” Proposed Fast-Track Alternative Approach to the 510(k) Pathway

By Nick Tippmann on January 10, 2018

This past month, the FDA drafted a guidance on a quick path to approval as an alternative to the 510...

5 Predictions for the Medical Device Industry in 2018 (And How You Can Prepare)

By Jon Speer on January 8, 2018

There is an old saying that the only thing that is constant in life is change. For the medical devic...

Greenlight Guru Medical Device Blog