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5 Myths Engineers Believe About Quality (and what is really true) - Featured Image

5 Myths Engineers Believe About Quality (and what is really true)

A well run medical device company is cross-functional in nature. Engineering, quality, regulatory, m...
How to Embrace Risk for Safer Devices - Featured Image

How to Embrace Risk for Safer Devices

No matter what you are working on, there are risks involved. Product development is complicated.
Sneak Peek Into the ISO 14971 Revision Process (From a Member of the Standard's Working Group, JWG1) - Featured Image

Sneak Peek Into the ISO 14971 Revision Process (From a Member of the Standard's Working Group, JWG1)

The ISO Technical Committee TC 210 Joint Working Group 1 (JWG1) is a committee that reports to not o...
7 Problems with a Paper-Based Design History File (And How to Avoid Them) - Featured Image

7 Problems with a Paper-Based Design History File (And How to Avoid Them)

If you’re using a paper-based system to manage your design history file (DHF), it can raise several ...
What You Need to Know About Risk Management and Using Post-Market Data - Featured Image

What You Need to Know About Risk Management and Using Post-Market Data

The aim for any medical device company is always to ensure that the devices they make are safe and e...
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?
Ultimate Guide to Corrective and Preventive Action (CAPA) for Medical Devices - Featured Image

Ultimate Guide to Corrective and Preventive Action (CAPA) for Medical Devices

  What Is This CAPA Guide About? As an experienced medical device professional who has worked with d...
What Does a Risk-Based QMS Mean? - Featured Image

What Does a Risk-Based QMS Mean?

What exactly is a risk-based QMS?
Why You Need To Stop Treating Risk Management & Design Controls as Checkbox Activities - Featured Image

Why You Need To Stop Treating Risk Management & Design Controls as Checkbox Activities

Understanding the relationship between product risk management and design controls is critical to th...
13 Common Pitfalls to Avoid During Medical Device Product Development - Featured Image

13 Common Pitfalls to Avoid During Medical Device Product Development

Are you falling into some of the common traps that surround medical device product development?

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