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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.

Regulatory Submission

Understanding FDA Cleared vs Approved vs Granted for Medical Devices

November 10, 2022
As a medical device professional, you are well aware of how much time and effort goes into getting your product to market. So, with so much care put in every part of the... Read More
Product Development

Computer Software Assurance for Medical Devices: What Does FDA’s Draft Guidance Mean for You?

October 7, 2022
On September 12th, 2022, FDA issued its latest draft guidance, which offers new recommendations for computer software assurance.  Read More
Establishing a QMS

Ultimate List of ISO Standards for Medical Devices

October 5, 2022
The International Standardization Organization (ISO) is an independent, non-governmental organization that has created thousands of international standards for numerous... Read More
Product Development

Medical Device Classification Guide - How To Determine Your Device Class

September 28, 2022
What I am about to share with you is a guide to medical device regulatory classification. Read More
Product Development

MEDDEV 2.7/1 Rev. 4 & MDCG Guidance: Carrying Out Clinical Evaluation Under EU MDR

September 16, 2022
When regulatory bodies need to clarify or establish expectations regarding a part of their regulations, they put out guidance documents. Read More
Establishing a QMS

5 Steps for Getting your CE Marking with EU MDR Requirements

September 5, 2022
It has long been thought that the quickest path to market for medical device manufacturers is to access the European market by obtaining a CE marking instead of going through... Read More
Product Development

Explaining MDCG 2019-11: Software Qualification & Classification for MDR & IVDR

September 2, 2022
Medical device software (MDSW) in the European Union is regulated by the European Commission (EC) via EU MDR and EU IVDR, and the classification rules for MDSW can be found... Read More
Product Development

3 Tips for Managing Your Medical Device Design History File

July 15, 2022
Your design history file (DHF) is one of the most critical components of your QMS. That’s because the DHF should contain all the product development documentation for a... Read More
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

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