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Taylor Brown

Taylor Brown
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.

Author's Posts

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

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

If you had told me three years ago that supply chain economics and logistics would become a popular ...
How Do FDA Medical Device Recalls Work? - Featured Image

How Do FDA Medical Device Recalls Work?

For medical device companies, few things are as valuable as the public’s trust.
Understanding the Quality Control Process in Medical Device Manufacturing - Featured Image

Understanding the Quality Control Process in Medical Device Manufacturing

The goal of any medical device is to improve the lives of its users.
Preparing for EUDAMED - Europe’s Medical Device Database - Featured Image

Preparing for EUDAMED - Europe’s Medical Device Database

In 2017, the European Commission (EC) released two new regulations, one specific to medical devices ...
Transitioning to IVDR: The New EU Regulation for In Vitro Diagnostic Medical Devices - Featured Image

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

In the European Union, in vitro diagnostic (IVD) devices are governed by a specific set of regulatio...
How to Approach Corrective Action Requests with Medical Device Suppliers - Featured Image

How to Approach Corrective Action Requests with Medical Device Suppliers

For medical device manufacturers, finding success means setting ourselves up for success with repeat...
3 Non-negotiables for Managing Business Risk as a Medical Device Company - Featured Image

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

How seriously do you take risk management? This may seem like an inane question, especially for a pr...
Creating a Quality Manual That Complies with ISO 13485 - Featured Image

Creating a Quality Manual That Complies with ISO 13485

An excellent quality management system (QMS) is one of the keys to bringing a safe and effective med...
How to Use the MDSAP Companion Document - Featured Image

How to Use the MDSAP Companion Document

When people speak of bringing a medical device “to market,” the location of that market is often lef...
3 Things Med Device Startups Must Do When Implementing a QMS - Featured Image

3 Things Med Device Startups Must Do When Implementing a QMS

I often hear early-stage medical device companies say they’re not ready for a quality management sys...
Recruiting Top Medical Device Talent in a Competitive Market - Featured Image

Recruiting Top Medical Device Talent in a Competitive Market

While robust growth in the medical device industry has seen more people coming into the field, it’s ...
What is a Quality Agreement for Medical Devices? - Featured Image

What is a Quality Agreement for Medical Devices?

There’s a good chance you’re not manufacturing your own medical device—contract medical device manuf...

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