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Combination product, drug, device and biologic
November 2, 2015

Two Key Processes You Must Know as a Combination Product Manufacturer

By David Amor
Combination product, drug, device and biologic

When preparing a regulatory submission, there are a couple of critical elements to consider.

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October 26, 2015

2015 Update on the Diabetes Market In Asia

By Ames Gross

As the incidence of diabetes across Asia expands, demand for medical devices and drugs to treat the disease is intensifying.

As the incidence of diabetes across Asia expands, demand for medical devices and drugs to treat the disease is intensifying.

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Achieving safety, quality and compliance in medical device software.
October 19, 2015

Medical Device Software Safety, Quality, and Compliance: What Really Makes A Difference?

By Carl Wyrwa
Achieving safety, quality and compliance in medical device software.

A look into the importance of high-quality software in the medical device industry.

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October 6, 2015

Does Your Supply Chain Challenge the Status Quo?

Regulations, cost pressures drive medical device companies to innovate.

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Joely Gardner, President and CEO, Human Factors Research
October 5, 2015

Will Your IFU Meet Usability Requirements?

By Joely Gardner
Joely Gardner, President and CEO, Human Factors Research

Well-written and usable instructions are critical for all users.

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Medical devices market in Russia, Intertek
September 29, 2015

Regulatory Changes and Market Access for Medical Devices in Russia

By Mark Miska
Medical devices market in Russia, Intertek

When entering this emerging market, the benefits may outweigh any risks.

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Japanese market, MedTech Intelligence
September 21, 2015

How to Succeed in Japan’s Medical Device Market

By Ames Gross
Japanese market, MedTech Intelligence

After preparing for three key issues, follow these recommended strategies when pursuing the market in Japan.

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Open Innovation
September 16, 2015

The Best Pre-Prototype Strategies

By Terri Marion
Open Innovation

Following these strategies will change how your company works with its outsourcing partners.

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Pre-Prototype Stages, new product development process
September 14, 2015

The Power of Pre-Prototype

By Terri Marion
Pre-Prototype Stages, new product development process

In product development, the earliest conceptual time period might be the most important.

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Product development roles and responsibilities in medical device manufacturing
September 11, 2015

How to Create Effective Relationships with Your Development Partner

By Art Rousmaniere
Product development roles and responsibilities in medical device manufacturing

As medical device companies move technology concepts into the commercialization stage, collaborating with outside partners is crucial.

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Upcoming Events & Webinars

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On Demand Events & Webinars

December 1, 2025
From Silos to Synergy: Building the Intelligent MedTech Lifecycle
September 17, 2025
Japan Medical Device Reimbursement Strategy
February 26, 2025
Are you talking to me? Communicating effectively with your Notified Body for an Accountable and Sustainable Working Relationship
January 21, 2025
Medical Device Labeling Best Practice for 2025: The Global Design Master
December 17, 2024
Adapt, Thrive, and Lead: Insights for Global Medical Device Executives
October 29, 2024
The Art of Benefit-Risk Calculation: Essential Tools for EU MDR Mastery
September 26, 2024
Adopting a RIM Platform in MedTech: Myths vs. Reality
August 27, 2024
Decoding global regulatory pathways: How to classify your Medical Device
July 31, 2024
Managing global regulatory strategy and compliance: assessing status, gaps, and needs.
July 18, 2024
Now that the EU MDR deadline is passed, how do you sell your device abroad?





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Upcoming Events & Webinars

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