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Quality Management – A Holistic Approach

Strategic quality management professionals envision a holistic solution across the entire product life cycle and supply chain that is able to

Support compliance
Detect risks and failures
Mit……

Global trends for Medical Device companies – An executive view from Terumo

In a series of interviews conducted by Dan Matlis, President of analyst firm Axendia, Terumo Cardiovascular Group executives Mark Lincoln, VP Global Operations, and Chris Zarecki, Director of Manufac……

Using Quality Systems to Gain Efficiency – Is that even possible?

Cost and Quality. They are often thought of as two sides in a game of “tug of war.” When one side gains traction the other loses. However, that is a very non-strategic view of how well-architected ma……

Why focusing on Quality rather than Compliance makes good business sense

In medical device manufacturing, as well as other regulated industries, we have served two masters. One is the end consumer, without whom we have no business. The other is the FDA (or other regulator……

Key criteria for getting faster ROI from your QMS implementation

Hopefully you are not thinking about how to get ROI on the Quality Management System you have already decided to invest in. If you’ve made the decision to invest funds, you’ve probably already made t……

Can you afford to aim for average? The cost of change in the med-tech industry

John F. Kennedy once said, “There are risks and costs to action. But they are far less than the long-range risks of comfortable inaction.” It is an appropriate concept for the state of the medical de……

Camstar Enterprise Platform v7 is now available

We are excited to announce the latest version of the Camstar™ Enterprise Platform has been released!

Version 7 is now available. Camstar is the leading manufacturing execution system (MES) in t……

Optimizing Product Quality across the Entire Lifecycle

As we move from a regulatory focus on compliance to one of proactively addressing product quality, some manufacturers are already ahead of the curve. They have focused their culture from the top down……

Digitalizing medical devices manufacturing

While medical device manufacturers are focused on bringing innovative products to market, many are in recall denial, believing that recalls affect other companies, not them.
Unfortunately, FDA’s re……