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How to Retroactively Create Design Controls and DHF (Even Though You Should Never Let This Happen) - Featured Image

How to Retroactively Create Design Controls and DHF (Even Though You Should Never Let This Happen)

  So, you haven’t completed your design controls or design history file (DHF)...
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.
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...
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 ...
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...
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...
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...
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...

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