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Top 35 Medical Device Conferences To Attend in 2019 - Featured Image

Top 35 Medical Device Conferences To Attend in 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 - Featured Image

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

FDA’s traditional compliance requirements establish a uniform quality system framework, but do not e...
FDA Case for Quality: 2018 Comprehensive Review - Featured Image

FDA Case for Quality: 2018 Comprehensive Review

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

Top 10 Most Popular Greenlight Guru Posts of 2018

Thank you for helping make 2018 another big and exciting year for Greenlight Guru!
ISO 13485 & MDSAP Deadlines are Fast Approaching (And You Need a Notified Body) - Featured Image

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

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) - Featured Image

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

A well run medical device company is cross-functional in nature. Engineering, quality, regulatory, m...
Regulatory Tips & Strategies from a Former FDA Reviewer - Featured Image

Regulatory Tips & Strategies from a Former FDA Reviewer

What are some recent trends and observations in the medical device industry regarding regulatory aff...
Why the FDA Case for Quality Matters - Featured Image

Why the FDA Case for Quality Matters

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 - Featured Image

21 CFR Part 11: A Complete Guide

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 - Featured Image

Scaling Regulatory and Quality with Your Company

  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 - Featured Image

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

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 - Featured Image

7 Questions About the European MDR Answered

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

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