Did you know... Medical interventions have become the third leading cause of death in America. An estimated 10 percent of Americans are implanted with medical d

In order for organizations to have high confidence in the reliability of their medical devices, they must ensure that each and every component or service meets

This reference provides real-world examples, strategies, and templates for the implementation of effective design control programs that meet current ISO 9000 an

The objective of the workshop that is the subject of this summary report was to present the challenges and opportunities for medical devices as perceived by the