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About the Author

Sara Adams is a Medical Device Guru at Greenlight Guru and a Certified ISO 13485 Lead Auditor who began her career in the medical device industry in the post-manufacturing world. As an experienced Quality Engineer, she has been responsible for leading Corrective and Preventive Action (CAPA) investigations and implementations, process improvements, and supplier and regulatory audits. Sara believes Quality is the responsibility of all medical device professionals, regardless of role or function, and enjoys helping customers achieve a state of constant audit-readiness by establishing and leveraging their medical device QMS software to improve the quality of life for patients.

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MedTech Lifecycle Excellence

How to Take Control of Training Management and Stay Compliant with ISO 13485:2016 and Part 820.25

March 27, 2024
In Greenlight Guru’s 2024 State of the MedTech Industry Report, respondents cited a number of common challenges related to training management, including: Read More
Product Development

3 Things to Love about Internal Audits

April 28, 2023
I have a confession to make—I love audits. I mean, I really love audits. Read More
Product Development

Creating a Periodic Safety Update Report (PSUR) that Complies with MDR & IVDR

February 1, 2023
The Periodic Safety Update Report (PSUR) is one of the new postmarket surveillance (PMS) activities required by EU MDR and EU IVDR. These new regulations represent a complete... Read More
Product Development

3 Types of QMS Audits (Plus 3 Tips to Prepare for Them)

January 15, 2023
The purpose of a QMS audit is to ensure your company has established the appropriate processes and procedures within your quality management system (QMS), and that those... Read More
Product Development

What is an ISO Audit?

January 3, 2023
When it comes to medical devices, compliance isn’t based on the honor system. Depending on where you intend to sell your device, you’ll undergo an ISO audit or inspection of... Read More
Establishing a QMS

What Should Really Trigger a CAPA?

January 30, 2022
Corrective and preventive action (CAPA) is often a thorn in the side of medical device manufacturers. Problems with CAPA top the list of reasons for 483s and warning letters... Read More
Product Development

Tips for Virtual Audits Your Medical Device Company Can Implement Today

December 7, 2021
Auditing medical device manufacturers is one of the most important aspects of ensuring quality standards. Read More
Establishing a QMS

What is ISO 9001 & Should Your Medical Device Company Follow It (or ISO 13485 instead)?

October 7, 2021
Quality management is an essential part of manufacturing any product, regardless of size, complexity, or intended use. Read More
Establishing a QMS

5 Biggest Quality Mistakes (And How You Can Avoid Making Them)

August 29, 2021
At Greenlight Guru, we collectively have hundreds of years of experience in medical device quality management. Read More

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