Ch 11 Managing Medical Devices within a Regulatory Framework

What is it about?

Understanding the stakeholders, evidence-based medicine (EBM) processes such as literature/clinical evaluation and clinical investigation, and the interdisciplinary approach to biomedical device integration that enhance clinical workflow and therefore, patient outcomes, are keys in the determination of purchasing additional operational assets in the form of new equipment and technology. While the EBM practices are still being disseminated across various stakeholders through education and regulation, the ability to converge international information becomes increasingly likely in the evaluation of medical devices. International summaries of medical device regulation for the United States and the European Union in this document provide a foundation for EBM. The recognition of stakeholders throughout the medical device total product life cycle (TPLC) is included to highlight the need for continuous safety data on medical devices in pre-marketing through post-surveillance. Comparative effectiveness strategies in the US and abroad are used to determine safety, performance, and treatment analysis provide examples of clinical evidence strategies in the US culminating in the systemic relevance of medical device integration into existing workflows. The document spans many important aspects used in the evaluation of new medical device purchases and provides additional resources for a short-and long-term understanding of the process by presenting various stakeholders and their outputs for decision-making along the product TPLC.

Featured Image

Why is it important?

The document spans many important aspects used in the evaluation of new medical device purchases and provides additional resources for a short-and long-term understanding of the process by presenting various stakeholders and their outputs for decision-making along the product Total Product Life Cycle (TPLC).