Methods for Medical Device Design, Regulatory Compliance and Risk Management

Abstract

Despite the evolution of design controls and compliance as critical elements in the medical device development process, as stipulated by both domestic and international regulations and standards, a comprehensive model describing the comprehensive approach to medical device design is needed. This gap exists because design controls and regulatory compliance have become integral to the medical device design process, mandated by regulations and standards at both national and international levels. The medical device sector prioritizes design controls and compliance with regulatory requirements in isolation. On the other hand, the integration of design controls and compliance, such as those associated with projects involving complex medical device designs, have not been considered nearly enough. This review focuses on the integration of design controls and compliance in the medical device sector. Initially, the definition of a medical device and the different phases of medical device development are introduced. Afterwards, medical device development using the basic safety and essential performance concepts outlined in the IEC 60601-1 standard is discussed. The role of risk management practices about medical devices is also elaborated upon.