Ch 4 Managing Medical Devices within a Regulatory Framework

What is it about?

Regulatory control is becoming increasingly important in the global manufacturing and distribution of medical devices. The various stages of the medical device encompasses detailed monitoring, adverse event reporting, and reimbursement processes geared to protect the public from adverse harm over the product life cycle of the device. Because of the extensive nature of the topic, we narrowed the topic discussion to a overview of premarketing/preclinical regulation leading to postmarketing regulation, agency reporting, postmarketing studies, and reimbursement strategies for the United States and the European Union, the two largest global medical device consumers/producers.

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Why is it important?

Understanding safety protocols in medical device development throughout the process contributes to national goals of patient safety.