Filter All Blog Posts

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.

Showing Results for

Establishing a QMS

Ultimate List of ISO Standards for Medical Devices

July 14, 2023
The International Standardization Organization (ISO) is an independent, non-governmental organization that has created thousands of international standards for numerous... Read More
Establishing a QMS

5 Steps for Getting your CE Marking with EU MDR Requirements

April 14, 2023
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

Complete Guide to Bringing a Medical Device to Market

March 20, 2023
Read More
Product Development

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

February 23, 2023
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
Product Development

What is a Class 2 Medical Device in the US?

February 4, 2023
The goal of anyone involved in medical devices is simple: produce high quality products that improve or save patient lives. Read More
Product Development

Computer Software Assurance for Medical Devices: What Does FDA’s Draft Guidance Mean for You?

October 7, 2022
In September 2022, the FDA issued a draft guidance that marks a significant transition in the MedTech industry's approach to software validation. 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
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

Experience the Guru Edge

Our industry expertise extends beyond our software. Explore our other resources that are helping leading MedTech companies reach success.


Accelerate your learning and proficiency - both in Greenlight Guru solutions and industry best practices. You’ll be equipped to build key competencies for your teams.

Elevate Your Education

You're not alone. We created a network of peers to connect with and learn from. At any stage of the product development lifecycle, become part of our community to accelerate your path to excellence.

Find Your Community
Partner Ecosystem

We have over 200 strategic partnerships with leading consultants in quality, regulatory, testing, design, and clinical.

Become a Partner

Do you have a unique problem that needs solving? Or maybe you’re just looking to elevate your expertise. If you're a MedTech professional looking to improve the quality of life for your patients, we have the right resources for you.

Explore Our Content Hub