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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.

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

Preparing for EUDAMED - Europe’s Medical Device Database

November 30, 2021
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

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. Read More
Product Development

How to Approach Corrective Action Requests with Medical Device Suppliers

November 14, 2021
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
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
Product Development

Creating a Quality Manual That Complies with ISO 13485

October 3, 2021
An excellent quality management system (QMS) is one of the keys to bringing a safe and effective medical device to market. Read More
Product Development

How to Use the MDSAP Companion Document

September 10, 2021
When people speak of bringing a medical device “to market,” the location of that market is often left unmentioned. That’s because worldwide, there are dozens of different... Read More

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