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ISO 13485 & MDSAP Deadlines are Fast Approaching (And You Need a Notified Body) - Featured Image

ISO 13485 & MDSAP Deadlines are Fast Approaching (And You Need a Notified Body)

In less than four months, come March 2019, the transitional period for medical device companies to c...
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 Drive Executive Engagement With Quality Systems (and actually get them excited about it) - Featured Image

How To Drive Executive Engagement With Quality Systems (and actually get them excited about it)

Most Quality people I know hear the same things over and over again. "Management isn't engaged." "Ma...
Quality vs Compliance Metrics (and what's next for FDA's Case For Quality) - Featured Image

Quality vs Compliance Metrics (and what's next for FDA's Case For Quality)

What is the FDA looking to drive forward in its Case for Quality initiative? 
5 Most Common Problems With Your CAPA Process - Featured Image

5 Most Common Problems With Your CAPA Process

What are the most common problems with the CAPA process?
Understanding the New Requirements for QMS Software Validation in ISO 13485:2016 - Featured Image

Understanding the New Requirements for QMS Software Validation in ISO 13485:2016

As I am sure many of you know, the ISO 13485 standard was updated in 2016, which means the time to t...
How to Determine the Operational Quality of a Quality System Using a Performance Assessment - Featured Image

How to Determine the Operational Quality of a Quality System Using a Performance Assessment

Are you ready for audits? ISO? FDA? Is your quality management system working the way you want it to...
Quality Management Audit or Assessment? - Featured Image

Quality Management Audit or Assessment?

What's the difference? Plenty! A typical audit only provides a sample understanding of the complianc...
Standard Conformity or Regulatory Compliance? Distinguishing the Two - Featured Image

Standard Conformity or Regulatory Compliance? Distinguishing the Two

So, you have a certificate hanging on your wall showing that you’ve passed an audit and conform with...
What Does a Risk-Based QMS Mean? - Featured Image

What Does a Risk-Based QMS Mean?

What exactly is a risk-based QMS? This is a timely topic to get into. In 2016, ISO 13485 was updated...
How to Switch to eQMS Software When You’re Just Using Paper - Featured Image

How to Switch to eQMS Software When You’re Just Using Paper

  How reliable is your paper-based QMS system? This situation plays out in medical device companies ...
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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