Medical Device Quality, Regulatory and Product Development Blog

7 Problems with a Paper-Based Design History File (And How to Avoid Them)

By Jon Speer on April 9, 2018

If you’re using a paper-based system to manage your design history file (DHF), it can raise several ...

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...

5 Most Common Problems With Your CAPA Process

By Nick Tippmann on March 21, 2018

What are the most common problems with the CAPA process?

Understanding the New Requirements for QMS Software Validation in ISO 13485:2016

By Kyle Rose on March 19, 2018

As I am sure many of you know, the ISO 13485 standard was updated in 2016, which means the time to t...

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...

Understanding the 5 Phases of Medical Device Development

By Adnan Ashfaq on March 5, 2018

Do you have a medical device to launch? Well I have good news for you and I have bad news for you.

What Substantial Equivalence Means as It Applies to 510(k)'s & Why It's Important

By Nick Tippmann on February 21, 2018

Do you have a firm grasp and understanding of what substantial equivalence means in regards to the 5...

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...

4 Tips for Handling Nonconformances

By Jon Speer on February 12, 2018

The safety and efficacy of your product rides heavily on the quality of the components that make it ...

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.

How to Structure Your Internal Audit Program for the New Year (Plus 4 Tips)

By Jon Speer on January 21, 2018

As your company heads back from holiday breaks, what’s happening into the New Year?

Greenlight Guru Medical Device Blog