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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.

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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

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

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
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
Establishing a QMS

5 Biggest Mistakes to Avoid when Seeking Funding for Your Medical Device

May 23, 2021
It doesn’t matter how great your medical device concept is—you’ll need some funding to get your idea off the ground. Read More
Product Development

How to Use the FDA ESG (Electronic Submissions Gateway)

March 28, 2021
The most competitive medical device companies embrace technology as a tool to make systems and processes more efficient - that’s one reason why the ESG (Electronic... Read More
Product Development

How to Demonstrate Substantial Equivalence in 5 Easy Steps

March 7, 2021
If you’re taking the 510(k) route to market for your medical device, demonstrating substantial equivalence is essential. Read More
Product Development

Understanding ISO 13485 Training and Competency Requirements

February 2, 2021
Are the employees in your medical device company meeting the training and competency requirements of the ISO 13485 standard for quality management systems? Read More

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