Ch 2 Managing Medical Devices within a Regulatory Framework

What is it about?

Medical device clinical trials are fundamental to international mandates for product safety. Consequently, attention to this topic is required to ensure that the safety of the general population is a high priority in order for new devices for diagnosis, treatment and rehabilitation to reach the market. Both industry innovation and regulation collaborate to provide devices for emerging markets and to improve on existing devices. This chapter introduces the mandatory procedures and marketing submission process for the United States and the European Union.

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Why is it important?

The general regulatory profiles of these two leading medical device producers/consumers are important because the US Market segment accounts for more than 50% and the EU for about 30% of the world’s growing $300+ billion dollar market.