Greenlight Guru Medical Device Blog

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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...
Challenges with Applying Risk Management Throughout the Manufacturing Process - Featured Image

Challenges with Applying Risk Management Throughout the Manufacturing Process

Today we’re going to be taking the topic of risk management to the next level. We are talking to Jim...
13 Steps to Creating a Risk-Based CAPA Process - Featured Image

13 Steps to Creating a Risk-Based CAPA Process

What does it mean to create a risk-based CAPA process? How should companies go about it?
The Do’s and Don’ts of an FDA Inspection - Featured Image

The Do’s and Don’ts of an FDA Inspection

The FDA has arrived at your premises…
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...

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