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MEDFlix

Maria Fontanazza and Ian Strickland discuss future of medtech market at AdvaMed 2015
October 15, 2015
Maria Fontanazza and Ian Strickland discuss future of medtech market at AdvaMed 2015

MedTech Market to Hit $470 Billion by 2020, Prepare for Consolidation

By MedTech Intelligence Staff

Expect to see slow growth and more mergers & acquisitions.

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John Babitt, Ernst & Young, Pulse of the Industry report at AdvaMed 2015
October 14, 2015
John Babitt, Ernst & Young, Pulse of the Industry report at AdvaMed 2015

2015 MedTech Highlights: Low Industry Growth, VC Declines, M&A Impressive

By MedTech Intelligence Staff

Ernst & Young’s Pulse of the Industry report is out, and once again, it’s not all gloom and doom.

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Carl Fischer, FDA, CDRH, Complaints, MedTech Intelligence
September 25, 2015
Carl Fischer, FDA, CDRH, Complaints, MedTech Intelligence

What Are Complaints and How Does FDA Handle Them?

By MedTech Intelligence Staff

CDRH’s Carl Fischer shares the agency’s approach to organizing and managing complaints.

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Dennis Gucciardo, Hogan Lovells, MedTech Intelligence, Integrated Complaint Management
September 24, 2015
Dennis Gucciardo, Hogan Lovells, MedTech Intelligence, Integrated Complaint Management

When Complaint Investigations Meet Servicing and Repairing Devices

By MedTech Intelligence Staff

Many companies are unsure of how to complete a complaint investigation when the service and repair process is involved.

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August 3, 2015

What Do FDA Investigators Look for During an Inspection?

By Maria Fontanazza

Getting into the mindset of an FDA investigator during an inspection is not necessarily easy.

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July 19, 2015

UL Discusses Cybersecurity Considerations for Medical Devices

Learn about the current guidance for Cybersecurity in the medical industry and strategies for how you can demonstrate to regulators, purchasers, and users that you’ve addressed these threats.

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July 2, 2015

How to Gather Clinical Evidence for Combination Products

By MedTech Intelligence Staff

Susan Alpert, principal of SFA Consulting, explains the role of clinical evidence for combination products and the complexities at play.

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July 1, 2015

Progress of FDA’s Office of Combination Products

By MedTech Intelligence Staff

What are the challenges faced by OCP?

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Supplier Responsibility in Medical Device Recalls
June 18, 2015
Supplier Responsibility in Medical Device Recalls

Supplier Responsibility in Medical Device Recalls

By Maria Fontanazza

What is the responsibility of the design owner? What level of accountability does the supplier have? What follow-up actions must a supplier take? A variety of best practices need to be driven forward by both suppliers and OEMs in an organized manner to ensure patient safety.

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Unannounced Audits
June 18, 2015
Unannounced Audits

European Device Regulations: Unannounced Audits

Critical subcontractors and crucial suppliers will be subject to unannounced audits by notified bodies under the revised European device regulations. Richard DeRisio of TÜV Süd provides more details in this presentation.

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Columns

March 29, 2017

Practical Advice for Your Regulatory Strategy

By MedTech Intelligence Staff
Susan Alpert, SFA Consulting, Global Regulatory Strategy

For companies in global markets, consider these three factors.

March 6, 2017

Should I Pursue Emerging Medtech Markets?

By MedTech Intelligence Staff
Matthew Hein, U.S. Department of Commerce

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

April 21, 2016

Connecting User Needs with Actionable Product Design Inputs

By MedTech Intelligence Staff

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

April 11, 2016

FDA Says Consider Device Context, Not Just Intended Use

By MedTech Intelligence Staff
FDA, Al Taylor, Risk

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

March 4, 2016

MedTech Blunders in Risk Management

By MedTech Intelligence Staff
Jon Speer, risk management

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

March 1, 2016

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

By MedTech Intelligence Staff
Mark Leimbeck, UL

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

February 12, 2016

Testing Devices Critical Part of Improving Patient Safety

By Maria Fontanazza
ECRI Instiute

This video demonstrates how ECRI Institute tests medical devices.

February 11, 2016

Why Duodenoscopes Are So Tough to Clean

By Maria Fontanazza
ECRI, duodenoscopes, endoscopes

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

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