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Tom Rish

Tom Rish
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.

Author's Posts

How to Use the FDA ESG (Electronic Submissions Gateway) - Featured Image

How to Use the FDA ESG (Electronic Submissions Gateway)

The most competitive medical device companies embrace technology as a tool to make systems and proce...
How to Demonstrate Substantial Equivalence in 5 Easy Steps - Featured Image

How to Demonstrate Substantial Equivalence in 5 Easy Steps

If you’re taking the 510(k) route to market for your medical device, demonstrating substantial equiv...
Understanding ISO 13485 Training and Competency Requirements - Featured Image

Understanding ISO 13485 Training and Competency Requirements

Are the employees in your medical device company meeting the training and competency requirements of...
How to Use the De Novo Pathway for your Medical Device - Featured Image

How to Use the De Novo Pathway for your Medical Device

Is the De Novo regulatory pathway a viable option to get your medical device to market?
What is the True Cost of Poor Quality for Your Medical Device Company? (Free Infographic) - Featured Image

What is the True Cost of Poor Quality for Your Medical Device Company? (Free Infographic)

For a lot of medical device companies, quality management can be a vexing issue. How much is enough?...
Everything You Need to Know about Human Factors Engineering for Your Medical Device - Featured Image

Everything You Need to Know about Human Factors Engineering for Your Medical Device

Human factors are a key part of medical device development and the sooner they’re addressed in the d...
7 FDA Pathways to Bring Your Medical Device to Market - Featured Image

7 FDA Pathways to Bring Your Medical Device to Market

Anyone reading this who is planning to launch a medical device in the U.S. has likely heard of the 5...
5 Steps for Getting your CE Marking with EU MDR Requirements - Featured Image

5 Steps for Getting your CE Marking with EU MDR Requirements

It has long been thought that the quickest path to market for medical device manufacturers is to acc...
Medical Device Classification Guide - How To Determine Your Device Class - Featured Image

Medical Device Classification Guide - How To Determine Your Device Class

What I am about to share with you is a guide to medical device regulatory classification.
How FDA Distinguishes Between Clearance vs. Approval vs. Granted - Featured Image

How FDA Distinguishes Between Clearance vs. Approval vs. Granted

As a medical device professional, you are well aware of how much time and effort goes into getting y...
Complete Guide to Bringing a Medical Device to Market - Featured Image

Complete Guide to Bringing a Medical Device to Market

The Greenlight Guru Medical Device Blog

Providing you actionable tips, best practices and insights for better medical device quality, compliance and product development.

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