Medical devices—Guidance on the application of ISO 14971
PLEASE NOTE: This document, known as a Draft Technical Information Report (DTIR), is not considered a final TIR and there may be slight editorial changes to the final publication. By ordering this draft, you'll be among the first to receive the final TIR, which is expected to be published in early 2020. When the final version is published, AAMI will send a link to download it to those who have purchased ANSI/AAMI/ISO DTIR24971.
SUMMARY: This Technical Report will provide guidance that addresses specific areas that experience has shown are problematic for those implementing a risk management system. This guidance would not require any change to existing implementations of ISO 14971. The proposed document would not be a general guidance on implementation of risk management. Such documents already exist from various sources. Rather the document envisioned would focus on expectations in certain critical areas such as guidance on formulation of a risk management policy; the role of product and process standards in the risk management process; guidance on how the feedback loop can work; guidance on the differentiation of information for safety as a risk control measure and disclosure of residual risk; and an expansion of the discussion of overall residual risk.
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