Evolution of Medtronic pacemakers, Maastricht

Most Popular Stories of 2015

Evolution of Medtronic pacemakers, Maastricht

A review of the articles you found most interesting this year.

Integrate human factors early in the development process.
Integrate human factors early in the development process.

5: How New FDA Expectations for Human Factors Affect Process and Medical Device Submissions

FDA’s perspective on human factors and usability engineering has evolved.

4: The Integration of Complaint Handling and Risk Management

A review of the important aspects of risk management and post-market surveillance processes, and how to resolve common concerns.

Medtronic, simulation training, Maastricht
At EM-TRAC, Medtronic brings in physicians to participate in simulation training.

3: Medtronic’s European Research Center Focuses on Innovation for Survival

The company’s Bakken Research Centre in the Netherlands is centrally located for technology development and collaboration with physicians.

2: Changes to ISO 13485: What to Expect

A summary of the new and revised changes in ISO 13485, the second Draft International Standard (DIS2).

1: Heigh-Ho, Heigh-Ho, It’s Off to Jail You Go

Charlie Chi, former CEO of OtisMed Corp, is sentenced to prison for shipping adulterated medical devices into interstate commerce.

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