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About the Author

Tom Rish is a Medical Device Guru at Greenlight Guru who works with customers to utilize their QMS software to build safer products on expedited timelines. He is a Biomedical Engineer who began his career developing implant and instrument systems in the orthopedic industry. He enjoys helping customers successfully navigate regulations across global markets as they bring life changing technologies to market.

Product Development

3 Medical Device Security Challenges (and Solutions)

January 16, 2022
Technological innovations in and around the medical device industry have made it possible for companies to create devices that deliver improved treatments, more precise... Read More
Product Development

Switching to an Electronic Device History Record (eDHR): What Medical Device Companies Should Know

December 21, 2021
Your device history record (DHR) is one of the final forms of documentation you’ll need before your product ships. That doesn’t mean it’s an afterthought, however.  Read More
Establishing a QMS

Ultimate List of ISO Standards for Medical Devices

November 28, 2021
The International Standardization Organization (ISO) is an independent, non-governmental organization that has created thousands of international standards for numerous... Read More
Product Development

Competent Authority, Notified Body, ISO Registrar: How Each Role Functions in the Medical Device Industry

November 8, 2021
To ensure quality and mitigate the risk of subjectivity or bias, the European and Canadian medical device regulatory landscape operate under a system of checks and balances... Read More
Product Development

What is a Class 2 Medical Device in the US?

November 2, 2021
The goal of anyone involved in medical devices is simple: produce high quality products that improve or save patient lives. Read More
Product Development

Medical Device 3D Printing: Should You Make the Move?

October 22, 2021
The medical device industry has grown immensely over the past several decades. But with new technological advances being made on a near-daily basis, the pace of growth is... Read More
Product Development

What is a Class 1 Medical Device?

October 8, 2021
In the US, the governing body tasked with regulating the medical device market is the Food and Drug Administration (FDA). More specifically, the Center for Devices and... Read More
Establishing a QMS

3 Medical Device Reimbursement Strategies to Recoup Your Investment in the US

September 19, 2021
Anyone who works in the medical device industry will tell you that quality and patient care is of the utmost importance. The ultimate reason why your products exist is to... Read More
Product Development

Understanding the Premarket Approval (PMA) Process

July 26, 2021
Before any medical device can hit the US market, FDA must first evaluate the product’s potential risk to the public. This is done in part through a risk-based classification... Read More

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