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

Top 35 Medical Device Conferences To Attend in 2019

By Nick Tippmann on January 29, 2019

Simply attending the right conferences can be a game-changer for those in the medical device industr...

Proactive Quality Systems: FDA Is Prioritizing Them...And You Should Too

By Stephanie Christopher, MA, Program Director, Case for Quality & Science of Patient Input on January 13, 2019

FDA’s traditional compliance requirements establish a uniform quality system framework, but do not e...

FDA Case for Quality: 2018 Comprehensive Review

By Jon Speer on January 1, 2019

Top 10 Most Popular Greenlight Guru Posts of 2018 - Featured Image

ISO 13485 & MDSAP Deadlines are Fast Approaching (And You Need a Notified Body)

By ECM (Ente Certificazione Macchine) on December 5, 2018

In less than four months, come March 2019, the transitional period for medical device companies to c...

5 Myths Engineers Believe About Quality (and what is really true)

By Jon Speer on November 4, 2018

A well run medical device company is cross-functional in nature. Engineering, quality, regulatory, m...

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...

Why the FDA Case for Quality Matters

By Jon Speer on September 13, 2018

When I first learned about the FDA’s Case for Quality initiative, I immediately wanted to learn more...

21 CFR Part 11: A Complete Guide

By Jon Speer on September 10, 2018

Medical device companies that wish to sell their devices in the US and EU must implement a quality m...

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?

AI Explainability: What That Means and Why it Matters in Healthcare

By Jon Speer on August 19, 2018

Is AI a topic we should be focused on in the medical device industry? Artificial Intelligence has ta...

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...

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