MEDICAL DEVICES DESIGN BASED ON EBD: A CASE STUDY

Abstract

The demands of designing safe and effective medical devices have significantly increased for the past decades. For example, Long [4] expressed a demand of improving current orthopedic medical devices by illustrating and discussing the uses, general properties, and limitations of orthopedic biomaterials. The emergence of fraudulent devices drove the need for regulations [5]. Countries all over the world have established their laws and regulations to systematically manage the medical devices in their respective markets. In the United States, for example, to assure the safety and effectiveness of medical devices in its market, the FDA (Food and Drug Administration) has established three regulatory classes based on the level of control: Class I General Controls (with or without exemptions), Class II General Controls and Special Controls (with or without exemptions), and Class III General Controls and Premarket Approval. For Class I and some Class II devices, simple controls will suffice for FDA clearance. Class III medical devices are subject to quality system requirements and stringent adverse event reporting and post-market surveillance [6]. For companies that produce Class III medical devices, a premarket approval (PMA) will be required before the devices can be marketed. This is because the risk to the user or patient determines that a mass of trials have to be done before approval [7]. All device manufacturing facilities are expected to be inspected every two years.