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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...
How to Streamline the Customer Complaint Handling Process - Featured Image

How to Streamline the Customer Complaint Handling Process

It can be quite nerve-wracking the very first time your medical device company receives a complaint ...
What Does a Risk-Based QMS Mean? - Featured Image

What Does a Risk-Based QMS Mean?

What exactly is a risk-based QMS?
Understanding the Connection Between Complaints, CAPAs, and MDRs - Featured Image

Understanding the Connection Between Complaints, CAPAs, and MDRs

Today we are going to talk about the connection between complaints, CAPAs, and MDRs. They are all in...
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...
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.
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 ...
Why Poor Design Controls Mean More Medical Device Complaints - Featured Image

Why Poor Design Controls Mean More Medical Device Complaints

I’ll venture a guess that you want to get your medical device to market ASAP!
Understanding ISO 14971 Medical Device Risk Management - Featured Image

Understanding ISO 14971 Medical Device Risk Management

Medical device companies MUST have established risk management processes that comply with ISO 14971.
How To Reduce & Prevent Medical Device Complaints - Featured Image

How To Reduce & Prevent Medical Device Complaints

Congratulations! You have successfully launched a new medical device after months and months of prod...

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