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  • AAMI
    AAMI TIR48:2015 - Quality Management System (QMS) Recommendations on the Application of the U.S. FDA\'s CGMP Final Rule on Combination Products
    Edition: 2015
    $655.65
    / user per year

Content Description

This Technical Information Report (TIR) provides information on how to effectively implement FDA’s regulation on Current Good Manufacturing Practices (CGMP) for combination products. Combination products are therapeutic or diagnostic medical products that combine drugs, devices, and/or biological products with one another, and the FDA regulation became effective July 22, 2013 (21 CFR Part 4).The TIR, where appropriate, also considers best practices, guidelines, and standards used both in the United States and other regions. The overall goal of the TIR is to aid informed, risk-based decisions in establishing CGMP operating systems that support development, manufacture, premarket regulatory evaluation, and ultimately commercialization of combination products. It should be noted that, while the information contained in the TIR has been carefully considered, it is up to the individual manufacturer to ensure compliance with all regulatory requirements that apply to its products.

About AAMI

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:
 
Contain costs
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.