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

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Accelerate development with integrated design control and risk software.

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Data collection and management designed for MedTech clinical trials.

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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.
Establishing a QMS
Etienne Nichols
February 2, 2024

FDA Publishes Final Rule on QMSR

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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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Ultimate Guide to ISO 14155:2020 for Medical Devices

Jon Bergsteinsson
September 15, 2023
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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

Key Actions for Effective Customer Complaint Handling

Jon Speer
December 6, 2021
Let's say, your medical device business has received a complaint from a customer. Read More
Product Development

7 Project Management Tips

Jon Speer
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

Jon Speer
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

Jon Speer
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)

Jon Speer
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

Jon Speer
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

Jon Speer
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
Establishing a QMS

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

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

How to Structure your Medical Device Technical File

Jon Speer
April 18, 2021
The medical device technical file is a must-have document for devices to be sold in the EU marketplace. Read More

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