The FDA has designated two AAMI risk management resources as recognized consensus standards: ANSI/AAMI/ISO 14971:2019, Medical devices—Application of risk management to medical devices and AAMI TIR97, Principles for medical device security—Postmarket risk management for device manufacturers.
A fundamental risk management standard, the newly updated ANSI/AAMI/ISO 14971:2019 establishes a process for medical device manufacturers to identify, evaluate, and mitigate risk. The 2019 update aligns the standard with international medical device regulatory changes and clarifies technical requirements. An accompanying draft technical report, AAMI/ISO DTIR24971:2020, Medical devices—Guidance on the application of ISO 14971, is currently available for preorder.
TIR97 is a new AAMI resource that provides detailed guidance for addressing the unique challenges of maintaining the security of a medical device during its entire life cycle. Designed to be used in conjunction with TIR57:2016, Principles for medical device security—Risk management, TIR97 provides guidance on performing postmarket security risk management for medical devices in the context of the safety risk management process required by ANSI/AAMI/ISO 14971.
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By attaining FDA recognition, voluntary consensus standards can be used in premarket submissions to demonstrate conformity with relevant FDA regulations and requirements.
Following a September 2018 guidance, the FDA indicates when a standard is targeted for recognition in its online database once that decision has been made. The newly listed standards then can be used immediately by medical device manufacturers to support their premarket submissions rather than waiting for publication in the Federal Register.
AAMI is a nonprofit organization founded in 1967. It is a diverse community of more than 9,000 healthcare technology professionals united by one important mission—supporting the healthcare community in the development, management, and use of safe and effective healthcare technology.