AAMI TIR45 is a technical information report published by the Association for the Advancement of Medical Instrumentation (AAMI). The report provides guidance on the use of the International Electrotechnical Commission (IEC) 62304 standard for the development of medical device software.
IEC 62304 is a widely recognized international standard for the software development process of medical devices. AAMI TIR45 provides additional guidance and recommendations for the application of IEC 62304 in the context of medical device software development.
The technical information report covers various aspects of the software development life cycle, including software requirements, software design, software testing, software configuration management, and software maintenance. It also includes guidance on the documentation required for each phase of the software development process and provides recommendations on risk management and validation activities.
AAMI TIR45 is intended to assist medical device manufacturers in achieving compliance with regulatory requirements, such as those set forth by the U.S. Food and Drug Administration (FDA) and the European Union Medical Device Regulation (MDR). By following the guidance in the report, manufacturers can ensure the safety and effectiveness of their medical device software and reduce the risk of noncompliance with regulatory requirements.