Land Use and Development
Rules & Regulations
Content DescriptionProvides guidance to manufacturers that change existing or create new alarm system algorithms as to how to create evidence that demonstrates a reasonable assurance of the safety and efficacy of the algorithm. This document also provides guidance to authorities having jurisdiction for the assessment of such evidence.
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The Association for the Advancement of Medical Instrumentation® (AAMI) is a nonprofit organization founded in 1967. It is a diverse community of more than 8,000 professionals united by one important mission—the development, management, and use of safe and effective health technology.
AAMI is the primary source of consensus standards, both national and international, for the medical device industry, as well as practical information, support, and guidance for healthcare technology and sterilization professionals. AAMI helps members:
Stay on top of new technology and policy developments
Add value in healthcare organizations
Improve professional skills
Enhance patient care
AAMI provides a unique and critical forum for a variety of professionals including clinical and biomedical engineers and technicians, physicians, nurses, hospital administrators, educators, scientists, manufacturers, distributors, government regulators, and others with an interest in healthcare technology. AAMI fulfills its mission through:
Courses, conferences, and continuing education, including certification programs.
Collaborative initiatives, including summits with the FDA
A rich array of resources, including peer-reviewed journals, technical documents, books, videos, podcasts, and other products.