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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.
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...
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...
Greenlight Guru Extends Platform with New Product, Grow, to Streamline PostMarket Quality Processes - Featured Image

Greenlight Guru Extends Platform with New Product, Grow, to Streamline PostMarket Quality Processes

The only eQMS specifically for medical device will enable companies to move beyond baseline complian...
How to Switch to eQMS Software When You’re Just Using Paper - Featured Image

How to Switch to eQMS Software When You’re Just Using Paper

  How reliable is your paper-based QMS system? This situation plays out in medical device companies ...
How Process Excellence Leads to Product Excellence - Featured Image

How Process Excellence Leads to Product Excellence

Today, we are talking to Mike Fisher, who is the director of product development at the Global Cente...
5 Tips for Conducting Medical Device Management Reviews - Featured Image

5 Tips for Conducting Medical Device Management Reviews

When was your last company management review? If you’re left scratching your head, it either may not...
Better Root Cause Analysis for Safer, More Effective Medical Devices - Featured Image

Better Root Cause Analysis for Safer, More Effective Medical Devices

Have you really figured out the root cause of any issues found in your medical device company?
CAPA: When to Take Corrective Action or Preventive Action? - Featured Image

CAPA: When to Take Corrective Action or Preventive Action?

How many of you can confidently initiate a CAPA and know exactly how and what to do and the process ...
Tips for Conducting Better Root Cause Analysis for Medical Device Companies - Featured Image

Tips for Conducting Better Root Cause Analysis for Medical Device Companies

At some point, every medical device development company will encounter an issue that requires an inv...
How SimplicityMD Is Leveraging Technology Plus a Lean Approach to Help Get Their Devices to Market Faster - Featured Image

How SimplicityMD Is Leveraging Technology Plus a Lean Approach to Help Get Their Devices to Market Faster

In today’s episode we continue our series on new breed medical device company stories. We talk with ...
Key Actions for Effective Customer Complaint Handling - Featured Image

Key Actions for Effective Customer Complaint Handling

  Let's say, your medical device business has received a complaint from a customer. It happens to al...

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