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

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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

3 Reasons Why Closed-Loop Traceability is a QMS Must

Jon Speer
September 27, 2020
There is a growing expectation in the medical device industry of manufacturers to demonstrate closed-loop traceability of all quality system processes. Read More
Product Development

519 Medical Device Manufacturers Reveal Biggest Barriers to Process Improvement

Jon Speer
August 30, 2020
In the medical device industry, there’s a lot outside of our control. The market shifts. New, innovative products replace old, inefficient ones. Regulations and standards... Read More
Product Development

Document Control for Medical Device Companies: The Ultimate Guide

Jon Speer
August 23, 2020
According to the original data findings of our 2020 State of Medical Device Product Development and Quality Management Report, over half of medical device manufacturers... Read More
Establishing a QMS

Unannounced Audits: A Survival Guide for Quality Managers

Jon Speer
August 16, 2020
We’re in an industry that requires preparation. Unlike less regulated industries, there’s an expectation in the medical device industry around the possibility that an... Read More
Product Development

How Do I Determine if my Product is a Medical Device?

Jon Speer
August 2, 2020
Let’s say you’re in the medical industry but not yet in the medical device industry. You’re working on a product that will serve the public health and help a select group of... Read More
Product Development

Top 100 Medical Device Acronyms & Terminology You Need to Know

Jon Speer
July 19, 2020
In the medical device industry, knowledge is power. Your knowledge of medical device terminology empowers you to work efficiently, communicate clearly, and mitigate errors... Read More
Product Development

How to Escape the Lure of Legacy Quality Management Systems

Jon Speer
July 12, 2020
Many device professionals in small to medium-sized businesses (SMB) still use legacy systems to support their quality management processes. Read More
Product Development

Medical Device Reporting (MDR): How to Take Advantage of Your Electronic Records

Jon Speer
July 5, 2020
Some companies in the medical device industry show resistance to digital technology, preferring to use the same paper systems they’ve used for decades. Read More
Product Development

How to Plan and Control the Design of your Medical Device while Meeting Regulatory Expectations

Jon Speer
June 28, 2020
What is the expected process you should follow for your medical device design planning and controls? Read More

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