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Greenlight Guru Medical Device Blog

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Approaching Cybersecurity & Usability as a SaMD Company - Featured Image

Approaching Cybersecurity & Usability as a SaMD Company

How do you balance security and usability of software as a medical device (SaMD)? It’s not easy and ...
Building a Culture of Quality - Featured Image

Building a Culture of Quality

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 - Featured Image

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

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 - Featured Image

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

On February 23, 2022, FDA released its proposed rule for the new Quality Management System Regulatio...
Human Factors & Risk Management: What's Needed & Why? - Featured Image

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

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? - Featured Image

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

What are the shortcomings, obstacles, and challenges when it comes to quality? Are there opportuniti...
Understanding the Quality Control Process in Medical Device Manufacturing - Featured Image

Understanding the Quality Control Process in Medical Device Manufacturing

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 - Featured Image

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

“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 - Featured Image

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

“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) - Featured Image

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

At Greenlight Guru, we collectively have hundreds of years of experience in medical device quality m...
Understanding the Value of a Medical Device Guru - Featured Image

Understanding the Value of a Medical Device Guru

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? - Featured Image

What is a Quality Agreement for Medical Devices?

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

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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