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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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featured

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

3 Valuable Outcomes of a Culture of Quality

Jon Speer
March 21, 2021
Do you consider your medical device company to have a culture of quality? Read More
Establishing a QMS

How Does a Medical Device Quality Management System Differ from other QMS Tools?

Jon Speer
January 26, 2021
Establishing a more efficient and effective quality management system (QMS) has been a recurring quest for nearly every medical device company I’ve worked with throughout my... Read More
Regulatory Submission

Submitting a 510(k)? First Make Sure You Know What 'Substantial Equivalence' Means

Jon Speer
January 25, 2021
Are you gearing up to submit a 510(k)? If so, you need to have a thorough understanding of what “substantial equivalence” means, and how it is a requirement of the 510(k)... Read More
Establishing a QMS

Definitive Guide to Change Management for Medical Devices

Jon Speer
January 22, 2021
In an industry that is ever-evolving, change is inevitable. Read More
Product Development

6 Benefits of the Best 21 CFR Part 11 Compliant Software

Jon Speer
December 13, 2020
Nearly every medical device company is subject to software validation requirements, regardless of whether your medical device has any software component at all. Remember that Read More
Product Development

12 Medical Device Experts Offer Best Tips for How to Succeed in 2021

Jon Speer
November 25, 2020
How will COVID-19, new regulatory programs and changes, and technological advancements impact your medical device company in 2021? With much uncertainty still on the horizon,... Read More
Product Development

Free Complaint Template for Medical Devices

Jon Speer
October 21, 2020
One of the major post-market responsibilities of medical device companies is handling customer complaints. However, unlike the complaints department at most businesses,... Read More
Product Development

Free Template: Nonconformance Process for your Medical Device

Jon Speer
October 20, 2020
Eventually, every quality professional is going to have to deal with nonconformance. In the medical device industry, there are too many moving parts for everything to go... Read More
Product Development

A Free CAPA Template for the Medical Device Industry

Jon Speer
October 18, 2020
If you’re a medical device professional, you’ve likely heard the acronym “CAPA” before. For those who aren’t familiar, it stands for “Corrective and Preventive Action,” and... Read More

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