Greenlight Guru Medical Device Blog

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Helping to Prepare Biomedical Engineers Entering the Workforce - Featured Image

Helping to Prepare Biomedical Engineers Entering the Workforce

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)! - Featured Image

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

Are you a smart, talented and ambitious individual looking to be surrounded by other elite performer...
Competitive Regulatory Strategy vs. Regular Regulatory Strategy - Featured Image

Competitive Regulatory Strategy vs. Regular Regulatory Strategy

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

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

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) - Featured Image

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

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) - Featured Image

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

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 - Featured Image

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

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 - Featured Image

5 Most Common Problems With Your CAPA Process

What are the most common problems with the CAPA process?
Understanding the New Requirements for QMS Software Validation in ISO 13485:2016 - Featured Image

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

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 - Featured Image

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

Are you ready for audits? ISO? FDA? Is your quality management system working the way you want it to...
Quality Management Audit or Assessment? - Featured Image

Quality Management Audit or Assessment?

What's the difference? Plenty! A typical audit only provides a sample understanding of the complianc...
Understanding the 5 Phases of Medical Device Development - Featured Image

Understanding the 5 Phases of Medical Device Development

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

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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