Verification & validation benchmarks for assessing and demonstrating the credibility of computational medical device evaluation

Computational modeling has become a powerful tool in the development as well as safety and efficacy assessment of medical devices and treatments. However, proper verification and validation is needed to be able to safely rely on computational modeling. Verification and validation approaches stemming from the engineering community are not readily applicable to problems involving the human body and in vivo effects. The issues, possible approaches, and need for adequate benchmarks (analytical, computational, and experimental) and uncertainty assessment will be discussed using examples from magnetic resonance imaging (MRI) safety and neuro-prosthetics.