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Discover the new trends, outlooks, challenges, and opportunities in the MedTech industry in 2023.

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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
Brittani Smith
February 26, 2023

Ultimate Guide to Postmarket Surveillance of Medical Devices

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Regulatory Submission

FDA 510(k) Submission: A Step-By-Step Guide On How To Prepare Yours

Jesseca Lyons
October 4, 2022
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Post-Market Surveillance

Selecting The Ideal PMCF Activity

Jon Bergsteinsson
July 17, 2022
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About the Author

Jon is the founder of Greenlight Guru (the leading cloud-based platform purpose-built for MedTech companies) and a medical device guru 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.

Establishing a QMS

Ultimate Guide to ISO 13485 for Medical Devices QMS

Jon Speer
February 16, 2023
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Establishing a QMS

Tips for Structuring Your Internal Audit Program (and Mistakes to Avoid)

Jon Speer
January 1, 2023
After a refreshing holiday break, there’s one question you need to ask yourself as you head into the new year: Do we have a plan in place for internal auditing this year? Read More
Product Development

Design Controls Need to Start With User Needs

Jon Speer
December 19, 2022
In the FDA’s classic design control waterfall diagram, the box at the left-hand top of the waterfall is labeled “user needs.” Read More
Establishing a QMS

How to Switch to eQMS Software When You're Just Using Paper

Jon Speer
December 5, 2022
How reliable is your paper-based quality management system? This situation plays out in medical device companies everywhere: Read More
Product Development

The Difference Between Intended Use and Indications of Use (And Why These Statements Are So Important)

Jon Speer
December 2, 2022
“Intended use” and “indications for use” are two of the easiest terms to confuse in the medical device industry. They’re often used interchangeably, not only because they... Read More
Establishing a QMS

CAPA Process: Step-by-Step Instructions [+ Free Infographic]

Jon Speer
November 15, 2022
The CAPA process is a frequent topic of discussion here at Greenlight Guru, mainly because it’s still such a big issue for medical device companies. Year after year, CAPA... Read More
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
Product Development

The Ultimate Guide To Design Controls For Medical Device Companies

Jon Speer
October 10, 2022
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Product Development

ISO 14971 Risk Management for Medical Devices: The Definitive Guide

Jon Speer
October 3, 2022
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