Biomedical signal acquisition systems: Towards a hybrid methodology for certification-based development

摘要

Regulatory agencies use certification to verify safety and effectiveness requirements of medical systems. Biomedical signal acquisition system is a type of medical system used to analyze the electrical activity from the patients' body, such as of the heart and stomach. Most of regulatory agencies conduct assessments using prescriptive standards and results of tests in physical systems. However, the use of prescriptive standards during the development process does not guarantee that the system is safe and effective. Besides, the identification of problems only in physical systems can increase costs of development and slow its market entry. I propose in this work a hybrid methodology for certification-based development. The methodology integrates process-based and product-based approaches to increase the confidence in biomedical signal acquisition systems. The overall approach is composed of three layers: manufacture system, exchange standard, and regulatory agency system.