Jessica Urban's blog

Why Does ISO 13485 Certification Matter?

In today’s medical device industry, it is becoming essential to select product development partners that have ISO 13485 certification. In fact, more and more medical device manufacturers are requiring their suppliers to be ISO 13485 certified.

Assessing Risk – Look Before You Leap

Assessing Risk Through Product DevelopmentIt is hard to avoid uncertainty in product development. Those that are seasoned in bringing products to market know that risk is an inevitable part of the development process. Project risks are lurking around every corner during product development. But don’t let that scare you.

From Medical Device Concept to Completion in Just 4 Steps

If you’ve ever tried to develop and market a medical device, you know that the development process is lengthy and time consuming. Most medical device manufacturers will waste valuable time and money by not knowing the flow of the full device development process, and a simple mistake can be costly.

Top Strategies for Simplifying Complicated Development Projects

Developing a medical device can often be time consuming and complicated, especially if your team is growing. One common hang up many medical device development companies experience is a breakdown in communication within medium- and large-sized organizations, especially when they grow or change staff members. By following these top strategies for simplifying complicated development projects, your organization will run much more smoothly as you develop your medical device.

The Phase Zero Process: Turning Potential Innovations Into Successful Products

The following article was published by MX Magazine in November 2011.

The Phase Zero process is a disciplined approach for turning potential innovations into successful medical devices.

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