Cart (0)
  • No.
There is a technical issue about last added item. You can click "Report to us" button to let us know and we resolve the issue and return back to you or you can continue without last item via click to continue button.
Search book title
Enter keywords for book title search
Search book content
Enter keywords for book content search
 Admin Code
 CADD File
 City Code
 Comprehensive Plan
 Conference Paper
 County Code
 DHS Documents
 Executive Regulation
 Federal Guideline
 Firm Content
 Land Use and Development
 Legislative Rule
 Local Amendment
 Local Code
 Local Document
 Local Regulation
 Local Standards
 Model Code
 Model Standard
 Rules & Regulations
 State Amendment
 State Code
 State Manual
 State Plan
 State Standards
 Study Guide
 Technical Bulletin
  • AAMI
    AAMI TIR48:2015/(R)2021 Quality Management System (QMS) Recommendations on the Application of the U.S. FDA’s CGMP Final Rule on Combination Products
    Edition: 2021
    / 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, guide-lines, 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.