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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

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
Establishing a QMS

3 Things Med Device Startups Must Do When Implementing a QMS

August 16, 2021
I often hear early-stage medical device companies say they’re not ready for a quality management system (QMS). Read More
Product Development

Recruiting Top Medical Device Talent in a Competitive Market

June 6, 2021
While robust growth in the medical device industry has seen more people coming into the field, it’s still highly competitive when it comes to recruitment. Read More
Product Development

What is a Quality Agreement for Medical Devices?

April 11, 2021
There’s a good chance you’re not manufacturing your own medical device—contract medical device manufacturing is growing at a compound annual growth rate of roughly 11%. Read More
Product Development

How to Use Voluntary Consensus Standards to your Strategic Advantage

February 28, 2021
If we were to say that it’s okay if you don’t follow all relevant standards when you develop your medical device, you’d probably think we were a bit crazy, right? Read More
Product Development

5 Ways to Leverage Internal Quality Audits to Improve External Audit Outcomes

February 14, 2021
Your internal quality audits should be much more than a “checkbox” requirement on your compliance to-do list. Internal audits must be regularly scheduled according to a... Read More
Establishing a QMS

Ultimate Guide to Training Management for Medical Device Companies

February 7, 2021
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Product Development

5 Key Principles of Total Quality Management

January 31, 2021
It's easy to think of quality as a niche responsibility, requiring only the involvement of those working in quality-based roles. Read More

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