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More than a Quality Management System: Tools for the entire MedTech Lifecycle.

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Document Management Training Management CAPA Management Audit Management Product Development

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Accelerate development with integrated design control and risk software.

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Design Controls Risk Management Risk Intelligence

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Data collection and management designed for MedTech clinical trials.

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Electronic Data Capture (EDC) Electronic Case Report Forms (eCRF) Electronic Patient Reported Outcomes (ePRO) Ad-Hoc Data Collection (Cases) Post-Market Surveys Product Add-Ons

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Posts by Jon Speer

Get the latest updates and best practices in the MedTech industry from our blog. Join 200,000+ other MedTech professionals outperforming their peers.
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Chris Rush
April 12, 2024

Ultimate Guide to Clinical Data Management in MedTech

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Establishing a QMS

FDA Publishes Final Rule on QMSR

Etienne Nichols
February 2, 2024
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Establishing a QMS

Guide to Managing Your Medical Device on the Market and Scaling Manufacturing

Laura Maher
January 3, 2024
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About the Author

Jon Speer is a medical device expert with over 20 years of 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.

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Establishing a QMS

What it Means to be Focused on Quality vs. Compliance

Jon Speer
September 30, 2018
Would you describe your company as quality focused? Read More
Product Development

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

Jon Speer
September 23, 2018
In today’s highly connected world, medical devices often include state-of-the-art software, or, the standalone software itself is considered a medical device. Read More
Establishing a QMS

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

Jon Speer
September 16, 2018
The long-term success of medical device companies depends on the strength of their foundation. Good document management is a critical component of this foundation – and in... Read More
Establishing a QMS

Why the FDA Case for Quality Matters

Jon Speer
September 13, 2018
When I first learned about the FDA’s Case for Quality initiative, I immediately wanted to learn more. Read More
Establishing a QMS

Scaling Regulatory and Quality with Your Company

Jon Speer
September 2, 2018
Have you thought about your systems and processes related to regulatory and quality standards? Read More
Establishing a QMS

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

Jon Speer
August 26, 2018
We recently launched a webinar series alongside the FDA, looking at its Case for Quality Program. Read More
Product Development

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

Jon Speer
August 19, 2018
Is AI a topic we should be focused on in the medical device industry? Artificial Intelligence has taken great strides and is a very topical issue now for medical device... Read More
Establishing a QMS

Why Your Company Needs a QMS Software or eQMS

Jon Speer
August 12, 2018
It’s time to face facts: a paper-based quality management system is no longer an option. Read More
Product Development

Challenging “Conventional Wisdom” in Medtech R and D

Jon Speer
July 29, 2018
The idea of “research versus development” can be highly controversial and much-debated among medical device circles. Where does the “R” end and the “D” begin? Read More

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