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About the Author

Taylor Brown is a Medical Device Guru, certified Lead Auditor for ISO 13485, and a card-carrying Quality Nerd. She got her start in the industry as a technical writer and quickly became an audit readiness and support specialist, traveling around the United States to establish ISO 13485 compliant quality systems. She enjoys working with customers to establish the right sized eQMS while improving the quality of life.

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Product Development

How To Approach Supplier Corrective Action Requests (SCAR)

September 15, 2023
For medical device manufacturers, finding success means setting ourselves up for success with repeatable processes that not only ensure quality, but also mitigate future risk. Read More
Establishing a QMS

How To Avoid a Failed QMS Implementation

April 16, 2023
No one implements a new QMS just for fun. Read More
Product Development

Preparing for EUDAMED - Europe’s Medical Device Database

October 3, 2022
In 2017, the European Commission (EC) released two new regulations, one specific to medical devices and the other for in vitro diagnostic medical devices. Read More
Product Development

Understanding Change Management and Change Control in the Medical Device Industry

June 22, 2022
Change is inevitable in the medical device industry. Innovative device companies are at the constant forefront of new technological advancements, regulations and standards... Read More
Product Development

4 Problems (and Solutions) for the Medical Device Supply Chain

March 18, 2022
If you had told me three years ago that supply chain economics and logistics would become a popular discussion topic, I would have raised an eyebrow or two. Read More
Product Development

How Do FDA Medical Device Recalls Work?

January 14, 2022
For medical device companies, few things are as valuable as the public’s trust. Read More
Product Development

Understanding the Quality Control Process in Medical Device Manufacturing

January 9, 2022
The goal of any medical device is to improve the lives of its users. Read More
Product Development

Transitioning to IVDR: The New EU Regulation for In Vitro Diagnostic Medical Devices

November 23, 2021
In the European Union, in vitro diagnostic (IVD) devices are governed by a specific set of regulations that distinguish them from other medical devices. Currently, IVDs are... Read More
Product Development

3 Non-negotiables for Managing Business Risk as a Medical Device Company

November 11, 2021
How seriously do you take risk management? This may seem like an inane question, especially for a professional in the medical device industry. Read More

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