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About the Author

Jon is the founder and VP of QA/RA at Greenlight Guru (MedTech Lifecycle Excellence platform exclusively for medical technology 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.

Product Development

Quality Assurance vs. Quality Control in the Medical Device Industry

May 19, 2022
Imagine that your medical device malfunctioned during patient use. Do you know whether quality assurance or quality control is responsible? When working through remediation... Read More
Product Development

7 Project Management Tips

October 28, 2021
When I began my medical device career, I started as a product development engineer. Part of the role included—right, wrong, or indifferent—project management. And I’ve found... Read More
Product Development

How to Execute a Successful Product Launch

September 26, 2021
Bringing a medical device to market can take anywhere from three to seven years, on average. The design and development of the device is a labor of love that can wind up... Read More
Product Development

Debunking 4 Commonly Held Design Control Myths

September 17, 2021
The design control struggle is real.What is the struggle, you ask? Design controls are not being used as an aid during medical device product development.  Read More
Product Development

How to Assess the Impact of Any Change to your Medical Device (+ Free Checklist)

September 13, 2021
So you need to make a change to your medical device, what now? Read More
Product Development

Driving Medtech Innovation with Safe and Effective Medical Devices

September 3, 2021
In the medical device industry, innovation is a complicated subject. Read More
Establishing a QMS

Understanding Intended Use from ISO TR 24971:2020

June 25, 2021
If you haven’t yet got into ISO TIR 24971:2020, there’s a fair bit to read up on. Read More
Product Development

ISO 14971 Risk Management for Medical Devices: The Definitive Guide

June 11, 2021
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Establishing a QMS

FDA QSR Transition to ISO 13485: Is Global Regulatory Harmonization on the Horizon?

May 28, 2021
Would things be simpler in the medical device regulatory space if there was global harmonization across all markets? Read More

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