Greenlight Guru Medical Device Blog

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4 Tips for Handling Nonconformances - Featured Image

4 Tips for Handling Nonconformances

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 - Featured Image

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

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) - Featured Image

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

As your company heads back from holiday breaks, what’s happening into the New Year?
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...
Ultimate List of Medical Device Incubators and Accelerators (50+) - Featured Image

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

Medical startups around the United States face many of the same challenges when it comes to achievin...
Evaluating FDA’s “New” Proposed Fast-Track Alternative Approach to the 510(k) Pathway - Featured Image

Evaluating FDA’s “New” Proposed Fast-Track Alternative Approach to the 510(k) Pathway

This past month, the FDA drafted a guidance on a quick path to approval as an alternative to the 510...
5 Predictions for the Medical Device Industry in 2018 (And How You Can Prepare) - Featured Image

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

There is an old saying that the only thing that is constant in life is change. For the medical devic...
Top 10 Most Popular Greenlight Guru Medical Devices Posts of 2017 - Featured Image

Top 10 Most Popular Greenlight Guru Medical Devices Posts of 2017

Thanks for helping make 2017 another big and exciting year for Greenlight Guru filled with tremendou...
An Overview of What Medical Device Developers Need to Know About Human Factors - Featured Image

An Overview of What Medical Device Developers Need to Know About Human Factors

The topic of human factors can be confusing: How does it relate to design factors and risk? Why is i...
15 Steps to Getting Approval for IEC 60601-1 - Featured Image

15 Steps to Getting Approval for IEC 60601-1

  Does your company have approval for IEC 60601-1? If you produce medical electrical equipment (MEE)...
Top 30+ Medical Device Conferences You Should Be Attending in 2018 - Featured Image

Top 30+ Medical Device Conferences You Should Be Attending in 2018

If you’re looking to land your company's next big deal, keep up on the latest regulatory trends, for...
How to Integrate Complaint Handling and Risk Management - Featured Image

How to Integrate Complaint Handling and Risk Management

Did you know that complaint handling continues to be a big reason medical device companies receive 4...

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Providing you actionable tips, best practices and insights for better medical device quality, compliance and product development.

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