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

How to Ensure Your Quality Management System is Effective and Benefits Patients

By Nick Tippmann on April 19, 2018

When it comes to quality management compliance, would you consider yourself a box checker or a true ...

What You Need to Know About Risk Management and Using Post-Market Data

By Jon Speer on March 26, 2018

The aim for any medical device company is always to ensure that the devices they make are safe and e...

How to Determine the Operational Quality of a Quality System Using a Performance Assessment

By Nick Tippmann on March 14, 2018

Are you ready for audits? ISO? FDA? Is your quality management system working the way you want it to...

Quality Management Audit or Assessment?

By Larry Mager on March 12, 2018

What's the difference? Plenty! A typical audit only provides a sample understanding of the complianc...

CAPA Process - Step-by-Step Instructions [Infographic]

By Jon Speer on February 20, 2018

CAPA is an area that we talk about often, mainly because it’s still such a big issue for medical dev...

Medical Device QMS Changes: How to Manage Changes Regarding EU MDR, IVDR & ISO 13485:2016

By Rod Beuzeval on January 30, 2018

One thing that seems to be constant in the global medical device industry is change.

Ultimate List of Medical Device Incubators and Accelerators (50+)

By Nick Tippmann on January 12, 2018

Medical startups around the United States face many of the same challenges when it comes to achievin...

5 Predictions for the Medical Device Industry in 2018 (And How You Can Prepare)

By Jon Speer on January 8, 2018

There is an old saying that the only thing that is constant in life is change. For the medical devic...

Greenlight Guru Extends Platform with New Product, Grow, to Streamline PostMarket Quality Processes

By Nick Tippmann on October 30, 2017

The only eQMS specifically for medical device will enable companies to move beyond baseline complian...

How to Switch to eQMS Software When You’re Just Using Paper

By Jon Speer on September 11, 2017

How reliable is your paper-based QMS system? This situation plays out in medical device companies ...

How Process Excellence Leads to Product Excellence

By Nick Tippmann on August 2, 2017

Today, we are talking to Mike Fisher, who is the director of product development at the Global Cente...

5 Tips for Conducting Medical Device Management Reviews

By Jon Speer on June 23, 2017

When was your last company management review? If you’re left scratching your head, it either may not...

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