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MEDFlix

Susan Alpert, SFA Consulting, Global Regulatory Strategy
March 29, 2017
Susan Alpert, SFA Consulting, Global Regulatory Strategy

Practical Advice for Your Regulatory Strategy

By MedTech Intelligence Staff
No Comments

For companies in global markets, consider these three factors.

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Matthew Hein, U.S. Department of Commerce
March 6, 2017
Matthew Hein, U.S. Department of Commerce

Should I Pursue Emerging Medtech Markets?

By MedTech Intelligence Staff
No Comments

Many companies go for product approval in smaller markets first. Is that the right decision?

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April 21, 2016

Connecting User Needs with Actionable Product Design Inputs

By MedTech Intelligence Staff
No Comments

Identifying user needs and actually turning them into actionable inputs during the design process can be a challenge.

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FDA, Al Taylor, Risk
April 11, 2016
FDA, Al Taylor, Risk

FDA Says Consider Device Context, Not Just Intended Use

By MedTech Intelligence Staff
No Comments

Device companies need to think about how their product interacts with systems and users.

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Jon Speer, risk management
March 4, 2016
Jon Speer, risk management

MedTech Blunders in Risk Management

By MedTech Intelligence Staff
1 Comment

A look at some common mistakes medical device companies make when approaching risk.

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Mark Leimbeck, UL
March 1, 2016
Mark Leimbeck, UL

Consistency Needed in Addressing IEC 60601-1 3rd Edition Risk Management

By MedTech Intelligence Staff
No Comments

There’s a greater emphasis on being able to demonstrate competence in performing required activities.

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ECRI Instiute
February 12, 2016
ECRI Instiute

Testing Devices Critical Part of Improving Patient Safety

By Maria Fontanazza
No Comments

This video demonstrates how ECRI Institute tests medical devices.

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ECRI, duodenoscopes, endoscopes
February 11, 2016
ECRI, duodenoscopes, endoscopes

Why Duodenoscopes Are So Tough to Clean

By Maria Fontanazza
No Comments

Complexity of design and frequency of use play a large role in how effectively scopes are reprocessed.

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Maria Fontanazza and Michael Lohan, IDA Ireland, AdvaMed 2015
November 6, 2015
Maria Fontanazza and Michael Lohan, IDA Ireland, AdvaMed 2015

Ireland Remains Competitive in Medical Device Sector

By MedTech Intelligence Staff
No Comments

With an established base of medtech companies and a strong workforce, Ireland remains a key player in the global supply chain.

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Joan Koerber-Walker and Maria Fontanazza, economic development in medtech, AdvaMed 2015
November 5, 2015
Joan Koerber-Walker and Maria Fontanazza, economic development in medtech, AdvaMed 2015

Finding the Right Ecosystem for MedTech Innovation

By MedTech Intelligence Staff
No Comments

In order to keep innovation and manufacturing in the United States, device companies need federal and local support.

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