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Jon Speer

Jon Speer
Jon is the founder and VP of QA/RA at Greenlight Guru (quality management software exclusively for medical device companies) & a medical device guru with nearly 20 years industry experience. Jon knows the best medical device companies in the world use quality as an accelerator. That's why he created Greenlight Guru to help companies move beyond compliance to True Quality.

Author's Posts

ISO 13485 - Ultimate Guide to Quality Management System (QMS) for Medical Devices - Featured Image

ISO 13485 - Ultimate Guide to Quality Management System (QMS) for Medical Devices

            TABLE OF CONTENTS Overview Evolution of Quality Systems General Requirements Documentati...
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...
15 Reasons WHY Medical Device Companies Choose Greenlight Guru - Featured Image

15 Reasons WHY Medical Device Companies Choose Greenlight Guru

The medical device industry has been undergoing a major shift for the past 20 years, and now that sh...
FDA Aligning to ISO 13485:2016 (and Why It Matters) - Featured Image

FDA Aligning to ISO 13485:2016 (and Why It Matters)

Earlier this year, the FDA announced their intentions to change the US’s current medical device regu...
What it Means to be Focused on Quality vs. Compliance - Featured Image

What it Means to be Focused on Quality vs. Compliance

  Would you describe your company as quality focused?
What are the Regulatory Expectations for Software as a Medical Device (SaMD)? - Featured Image

What are the Regulatory Expectations for Software as a Medical Device (SaMD)?

  In today’s highly connected world, medical devices often include state-of-the-art software, or, th...
The Importance of Good Document Management (And How To Do It) - Featured Image

The Importance of Good Document Management (And How To Do It)

The long-term success of medical device companies depends on the strength of their foundation. Good ...
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 mo...
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?
FDA Case for Quality Program: What, Why and How? - Featured Image

FDA Case for Quality Program: What, Why and How?

We recently launched a webinar series alongside the FDA, looking at its Case for Quality Program. Th...
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?

The Greenlight Guru Medical Device Blog

Providing you actionable tips, best practices and insights for better medical device quality, compliance and product development.

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