greenlight.guru Medical Device Blog

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An Overview of What Device Makers Need to Know About CAPA - Featured Image

An Overview of What Device Makers Need to Know About CAPA

Today we will be talking about a topic that seems to be an area of continual concern and, in some ca...
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...
5 Tips for Medical Device Engineers on FDA Design Controls - Featured Image

5 Tips for Medical Device Engineers on FDA Design Controls

If you’re in the medical device industry, you may think that design controls are a confusing imposit...
How Surgical Innovation Associates Found the Benefit of Quality Beyond Just Compliance - Featured Image

How Surgical Innovation Associates Found the Benefit of Quality Beyond Just Compliance

At greenlight.guru, we would like to continue our series on the new breed of medical device companie...
9 Keys to Enacting CAPA for Medical Devices Following Your Internal Audit - Featured Image

9 Keys to Enacting CAPA for Medical Devices Following Your Internal Audit

Most of us really don’t get excited by the prospect of any kind of audit. The procedures, the paperw...
Best Practices for Expediting Your Medical Device Product Development - Featured Image

Best Practices for Expediting Your Medical Device Product Development

Speed to market is one of the major challenges for medical device companies; how can you expedite th...
Significant Risk vs. Nonsignificant Risk Devices - What's the Difference? - Featured Image

Significant Risk vs. Nonsignificant Risk Devices - What's the Difference?

Do you understand the difference between significant risk and nonsignificant risk when it comes to t...
4 Key Compliance Issues for Medical Device Companies - Featured Image

4 Key Compliance Issues for Medical Device Companies

The goal for most creators of new medical devices is to be able to get them to market as quickly as ...
What is CAPA in the Medical Device Industry? - Featured Image

What is CAPA in the Medical Device Industry?

If you’re relatively new to the medical device development industry, you will have worked out fairly...
Key Challenges for Risk Management in Medical Device Development - Featured Image

Key Challenges for Risk Management in Medical Device Development

If you’re in the business of developing medical devices, then risk and risk management become terms ...

The greenlight.guru Medical Device Blog

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