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Unannounced Audits: A Survival Guide for Quality Managers - Featured Image

Unannounced Audits: A Survival Guide for Quality Managers

We’re in an industry that requires preparation. Unlike less regulated industries, there’s an expecta...
How to Build a QMS for a Medical Device - Featured Image

How to Build a QMS for a Medical Device

Where do you begin when building a quality management system (QMS) for a medical device? It’s a task...
Medical Device Reporting (MDR): How to Take Advantage of Your Electronic Records - Featured Image

Medical Device Reporting (MDR): How to Take Advantage of Your Electronic Records

Some companies in the medical device industry show resistance to digital technology, preferring to u...
Understanding Post-Market Surveillance Requirements for Medical Devices (US & EU Markets) - Featured Image

Understanding Post-Market Surveillance Requirements for Medical Devices (US & EU Markets)

As leaders of medical device companies, our goal is always to create devices that are safe and effec...
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 ...

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

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