Medical Device Quality, Regulatory and Product Development Blog | Greenlight Guru

Approaching Cybersecurity & Usability as a SaMD Company

By Nick Tippmann on May 27, 2022

How do you balance security and usability of software as a medical device (SaMD)? It’s not easy and ...

Building a Culture of Quality

By Nick Tippmann on May 20, 2022

How do you build a company that puts culture before function? Results before profit? Building a cult...

4 Problems (and Solutions) for the Medical Device Supply Chain

By Taylor Brown on March 18, 2022

If you had told me three years ago that supply chain economics and logistics would become a popular ...

QMSR (Quality Management System Regulation) Explained: What FDA QSR & ISO 13485 Harmonization Means for Medical Device Companies

By Etienne Nichols on March 2, 2022

On February 23, 2022, FDA released its proposed rule for the new Quality Management System Regulatio...

Human Factors & Risk Management: What's Needed & Why?

By Nick Tippmann on March 2, 2022

Don’t give up on risk management. It’s the backbone of the product development lifecycle and human f...

What are the Opportunities for Improvement (OFI) for Quality?

By Nick Tippmann on February 23, 2022

What are the shortcomings, obstacles, and challenges when it comes to quality? Are there opportuniti...

Understanding the Quality Control Process in Medical Device Manufacturing

By Taylor Brown on January 9, 2022

The goal of any medical device is to improve the lives of its users.

Case Study: How a Partnership with Greenlight Guru is Making This Dental Device Manufacturer Smile

By Nick Tippmann on September 28, 2021

“Partnering with Greenlight Guru provides you with a team that’s on your side, who are all medical d...

Case Study: How The Partner Ecosystem Has Been Key To Market Success For Spark Biomedical

By Nick Tippmann on September 24, 2021

“Having partners with common values is just as important as the product or services themselves.” Dan...

5 Biggest Quality Mistakes (And How You Can Avoid Making Them)

By Sara Adams on August 29, 2021

At Greenlight Guru, we collectively have hundreds of years of experience in medical device quality m...

Understanding the Value of a Medical Device Guru

By Nick Tippmann on May 26, 2021

Have you ever wondered, what does a medical device guru actually do? What role do they play within G...

What is a Quality Agreement for Medical Devices?

By Taylor Brown on April 11, 2021

There’s a good chance you’re not manufacturing your own medical device—contract medical device manuf...

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