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.

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.