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

Tips for Running Effective Internal Quality Audits

By Jon Speer on June 4, 2018

How did your last internal quality audit go?

How Priority Designs Used Greenlight Guru to Gain ISO 13485:2016 Certification

By Nick Tippmann on May 25, 2018

We have many different types of companies using Greenlight Guru to help them create a compliant qual...

How SOLIUS Went from Scratch to an eQMS and ISO 13485:2016 Certification

By Nick Tippmann on May 25, 2018

It can be challenging for small companies to navigate the medical device regulatory pathways, especi...

Sneak Peek Into the ISO 14971 Revision Process (From a Member of the Standard's Working Group, JWG1)

By Edwin Bills, ASQ Fellow, RAC on May 14, 2018

The ISO Technical Committee TC 210 Joint Working Group 1 (JWG1) is a committee that reports to not o...

Tips, Tricks & Best Practices for Complying with ISO 13485:2016

By Nick Tippmann on May 8, 2018

When it comes to ISO 13485:2016, are you scrambling to meet requirements? Are you trying to figure o...

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...

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