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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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Product Development

Best Practices for Effective Medical Device Design Reviews

Jon Speer
January 20, 2019
Design Reviews are intended to be checkpoints during medical device product development to ensure the product design is safe, effective, and progressing. Read More
Product Development

Why Contract Manufacturers Shouldn't Own Your Quality System

Jon Speer
January 7, 2019
Does your medical device company use a third-party or contract manufacturer? Read More
Product Development

FDA Case for Quality: 2018 Comprehensive Review

Jon Speer
January 1, 2019
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Establishing a QMS

Defining Your Medical Device Design Records

Jon Speer
December 18, 2018
It’s easy to get a bit confused when you consider the records that are required for your medical device. Read More
Product Development

6 Predictions for the Medical Device Industry in 2019 (and how you can prepare)

Jon Speer
December 9, 2018
Within the past couple of years, we have experienced significant changes in the medical device industry. Read More
Establishing a QMS

FDA Computer System & Software Validation - What You’ve Known For 20+ Years Is Changing

Jon Speer
December 2, 2018
NOTE: The FDA draft guidance on Computer Software Assurance for Production and Quality System Software is now available. For more information, check out our articles on ... Read More
Establishing a QMS

3 Real World Document Management Horror Stories

Jon Speer
November 25, 2018
In the medical device world, it’s not uncommon to get hung up on documentation. “It takes too much time.” “It’s throwing us off our concentration.” Read More
Product Development

5 Myths Engineers Believe About Quality (and what is really true)

Jon Speer
November 4, 2018
A well run medical device company is cross-functional in nature. Engineering, quality, regulatory, manufacturing, sales, marketing, finances, Read More
Establishing a QMS

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

Jon Speer
October 7, 2018
Earlier this year, the FDA announced their intentions to change the US’s current medical device regulations from FDA 21 CFR Part 820 to ISO 13485:2016. This is kind of a big... Read More

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