Medical device design process.

The current design process is a combination of methods from engineering disciplines, government regulatory agencies (domestic and international) and independent certification and compliance companies. The goal of the processes that have been developed is to be certain that a new product meets the users expectations, is safe and effective in providing its claimed benefits. As products have become more complex and particularly with regard to software control it has become increasingly more difficult to determine the safety and efficacy of a product by inspection or after the fact testing alone.

Medium voltage therapy for preventing and treating asystole and PEA in ICDs.

Introduction: Sudden cardiac death (SCD) takes up to 500,000 lives each year before a victim can even be treated. To address this the implantable cardioverter defibrillator (ICD) was developed to treat those identified at high risk of SCD. Unfortunately, there are a significant number of cases in which the ICD does not successfully return a victim to normal rhythm and effective perfusion of the blood.