In the medical device industry new devices are brought to market after verification and
validation (V&V) testing, pending the Food and Drug Administration's (FDA) approval. There …

Evaluation of medical devices via clinical trial is often a necessary step in the process of
bringing a new product to market. In recent years, device manufacturers are increasingly …

High product quality and reliability are critical in the medical device industry. Accurate
reliability prediction during the product development stage provides inputs for the design …

A medical device is broadly defined as a device designed through mechanical and electrical
engineering intended to affect the structure or any function of the human body and which …

Abstract" Statistical Viewpoint" addresses principles of statistics useful to practitioners in
compliance and validation. The authors intend to present these concepts in a meaningful …

Presently, most contracls for hardware development include a numerical reliability
requirement in the specification. In addition, they often require quantitatively demonstrated …

Medical device manufacturers are responsible for ensuring that their medical products are
safe. Manufacturers and medical device users have an important role to play in maintaining …

Risk analysis methods for medical devices, including fault tree analysis, have limitations
such as handling uncertainty and providing reasonable risk estimates with limited or no …

This paper provides an assessment method to compare design alternatives, the method
starts as early as the concept development phase of a system. The method uses Bayesian …

The worldwide market for medical devices is roughly $200 B, with close to $100 B in the
United States alone. Since product failures may result in patient and user injury or death …