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About the Author

Jon is the founder and VP of QA/RA at 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.

Product Development

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

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]

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
Regulatory Submission

7 Tips to Comply With FDA 21 CFR Part 11

October 28, 2022
When it comes to regulatory compliance for medical device companies, there can be some confusion around FDA 21 CFR Part 11.  Read More
Product Development

Quality Assurance vs. Quality Control in the Medical Device Industry

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

October 10, 2022
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Establishing a QMS

21 CFR Part 11: A Complete Guide

October 5, 2022
Medical device companies that wish to sell their devices in the US and EU must implement a quality management system that meets the requirements of 21 CFR Part 820 and ISO... Read More
Establishing a QMS

Ultimate Guide to ISO 13485 for Medical Devices QMS

October 3, 2022
  Table of Contents What is ISO 13485 Evolution of a Quality Management System Requirements for ISO 13485 Certification ISO 13485... Read More
Product Development

ISO 14971 Risk Management for Medical Devices: The Definitive Guide

October 3, 2022
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Product Development

3 Tips For Incorporating Risk Management During Medical Device Product Development

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

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