Medical Device Quality, Regulatory and Product Development Blog

Helping to Prepare Biomedical Engineers Entering the Workforce

By Nick Tippmann on April 24, 2018

Students offer hope for our future. They will be developing products that can save our lives, or at ...

Looking to join a fun, fast growing SaaS company? Greenlight Guru is hiring in all areas (Again)!

By Nick Tippmann on April 23, 2018

Are you a smart, talented and ambitious individual looking to be surrounded by other elite performer...

Competitive Regulatory Strategy vs. Regular Regulatory Strategy

By Jon Speer on April 23, 2018

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 ...

Timeline to ISO 13485:2016 (And Why You Need to Act Today)

By Jon Speer on April 15, 2018

To be blunt, if your company has put off doing anything about ISO 13485:2016, you need to act immedi...

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.

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