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

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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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Product Development

Quality Assurance vs. Quality Control in the Medical Device Industry

Jon Speer
October 10, 2022
Imagine that your medical device malfunctioned during patient use. Do you know whether quality assurance or quality control is responsible? When working through remediation... Read More
Establishing a QMS

What is a Quality Culture? (and 7 Tips for Creating One)

Jon Speer
October 1, 2022
In the medical device industry, the word quality can mean different things to different people. To some, meeting compliance requirements is quality. To others, quality is... Read More
Product Development

3 Tips For Incorporating Risk Management During Medical Device Product Development

Jon Speer
September 30, 2022
Medical device product development and risk management are often treated as entirely separate processes. Sure, there is usually acknowledgement and understanding that these... Read More
Product Development

15 Steps to Getting Approval for IEC 60601-1

Jon Speer
September 26, 2022
Does your company have approval for IEC 60601-1? If you produce medical electrical equipment (MEE) or systems you soon will have to as this general standard applies to all... Read More
Product Development

FDA De Novo Pathway: Process Explained for Medical Device Companies

Jon Speer
May 13, 2022
The De Novo pathway has been around for more than two decades, but it is still one of the least used pathways by medical device companies when bringing a product to market. Read More
Establishing a QMS

7 Tips to Attract Investors and Raise Funds for your Medical Device

Jon Speer
May 6, 2022
Is your medical device company in the midst of raising funds or planning to begin the process? There are many stages of the fundraising process you may find yourself in,... Read More
Post-Market Surveillance

How to Streamline the Customer Complaint Handling Process

Jon Speer
April 13, 2022
It can be quite nerve-wracking the very first time your medical device company receives a complaint from a customer. What are your next steps? Is this something serious? Read More
Product Development

FDA Inspections and ISO Audits: What is the Difference?

Jon Speer
March 13, 2022
It’s every medical device manufacturer's favorite time…the arrival of an FDA inspector or ISO auditor to your facility. Read More
Regulatory Submission

The Definitive Guide to Responding to FDA 483 Observations and Warning Letters

Jon Speer
January 13, 2022
Should you ever have an FDA inspection, you’re going to want to know what to do after. And if you’re a medical device company with class II or class III products registered... Read More

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