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Debunking 8 Commonly Held CAPA Myths - Featured Image

Debunking 8 Commonly Held CAPA Myths

  CAPA is a source of ongoing issues within medical device companies.
The Intersection of Medical Device Usability and Risk Management - Featured Image

The Intersection of Medical Device Usability and Risk Management

Today we’re going to be talking to our good friend Mike Drues from Vascular Sciences about the inter...
What is a “Quality Data Source” for your CAPA Process? - Featured Image

What is a “Quality Data Source” for your CAPA Process?

There’s a phrase that the FDA states in their policies around CAPA, which elicits a few questions. T...
What Should Really Trigger a CAPA? - Featured Image

What Should Really Trigger a CAPA?

Over years of working with medical device companies, we’ve found that there is a particular area tha...
EN ISO 14971:2012 risk assessment explained in 5 minutes... using the grossest example ever? - Featured Image

EN ISO 14971:2012 risk assessment explained in 5 minutes... using the grossest example ever?

  This post was originally published by David Amor on LinkedIn and reposted here with the author's p...
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...
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 ...
Using the Bucket Method for Medical Device Risk Management - Featured Image

Using the Bucket Method for Medical Device Risk Management

Risk management: It’s a topic that needs to be navigated carefully by medical device companies. It’s...
Medical Device Risk – ISO 14971 Gets It Right - Featured Image

Medical Device Risk – ISO 14971 Gets It Right

Editor's note: This is a guest post authored by William Storage, VP LiveSky Inc., Visiting Scholar, ...
Why Use ISO 14971 vs. FMEA (Template Included) - Featured Image

Why Use ISO 14971 vs. FMEA (Template Included)

This may be stating the obvious, but engineers are generally very analytical. One of the areas where...
8 Reasons Why Your Design Controls And Risk Management Processes Fail - Featured Image

8 Reasons Why Your Design Controls And Risk Management Processes Fail

Design controls and risk management processes should be tools for medtech professionals to ensure th...
Understanding Risk in Medical Device New Product Development (NPD) - Featured Image

Understanding Risk in Medical Device New Product Development (NPD)

Editor's Note: This is a guest post by Jeff Groh, President at New Product Visions and was originall...

The greenlight.guru Medical Device Blog

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