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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

[VIDEO] 7 Ways to Track QMS Effectiveness using Medical Device Post-market Quality Processes (Track Phase)

Jon Speer
February 14, 2020
How can I track the effectiveness of my QMS after my medical device goes to market? We'll cover the procedures you need to establish to maintain quality control of your... Read More
Establishing a QMS

[VIDEO] How to Prepare your QMS for a Successful Medical Device Product Launch (Release Phase)

Jon Speer
February 14, 2020
Is my QMS ready for the product launch of my medical device? Which quality processes should I implement to prepare for my product release into the market? We’ll help you... Read More
Establishing a QMS

[VIDEO] 4 Medical Device Manufacturing Best Practices for a Successful Design Transfer (Approve Phase)

Jon Speer
February 14, 2020
How can I prepare my QMS to approve my medical device for manufacturing from a design transfer? Learn the key quality processes to establish in your QMS in the final... Read More
Establishing a QMS

[VIDEO] Integrating Design Controls & Risk Management To Streamline Product Development (Make Phase)

Jon Speer
February 14, 2020
Which QMS processes should be established during product development? We'll explain how design controls and risk management QMS processes should guide your product... Read More
Establishing a QMS

[VIDEO] 3 Easy Steps to Establishing a Quality & Regulatory Strategy for your Medical Device (Scope Phase)

Jon Speer
February 14, 2020
How do I know which regulations apply to my medical device? What should I include in my quality plan to ensure ongoing compliance and success of my medical device? We’ll... Read More
Establishing a QMS

[VIDEO] How to build a QMS using the best people, processes & technology (S.M.A.R.T Methodology)

Jon Speer
February 14, 2020
Which quality processes should I establish first when implementing a quality management system (QMS)? Learn how to leverage your best people, processes, and technology... Read More
Product Development

The Art of Defining Design Inputs And Design Outputs

Jon Speer
January 8, 2020
Design inputs are the king of medical device product development. If a product that is in the market has issues, odds are the issue can be traced back to the design inputs... Read More
Establishing a QMS

FDA 21 CFR Part 820: 8 Most Common Mistakes to Avoid

Jon Speer
November 27, 2019
If you’re a medical device company selling or planning to sell into the US market, you should be familiar with FDA's 21 CFR Part 820 Quality System Regulation (QSR). Read More
Product Development

State of Medical Device Product Development and Quality Management Report 2020

Jon Speer
November 25, 2019
Greenlight Guru, the only medical devicequality management system(MD QMS) software platform, today announced findings from the “State of Medical Device Product Development... Read More

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