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AAMI TIR38

Medical device safety assurance case report guidance

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Organization: AAMI
Publication Date: 1 January 2019
Status: active
Page Count: 51
scope:

This TIR is a safety case development reference for medical device design. The TIR is intended to provide a framework within which experience, insight, and judgment are applied systematically to assure and document the safety of a medical device's design.

This TIR is not intended to be a prescriptive guidance for the development and documentation of safety cases. This TIR also does not address all necessary activities required to assure that the device, as presented to the user / patient, is fit for use.

In order to simplify this TIR, this guidance has an assumption that the reader is familiar with the hazards for a particular type of product and is not designing a new-to-world product. While the techniques in this guidance can be used for innovative products, this TIR is targeted at existing, well understood products.

Finally, this guidance is written with a focus on "design safety assurance", emphasizing design inputs, design outputs, verification, and validation. The same techniques can be used for developing a "good manufacturing practice (GMP) safety assurance", which accounts for verification and validation of the manufacturing and quality process controls. It is suggested, though not required, that a safety case include both aspects of the design and GMP elements of the medical device in order to effectively argue that the device as a system is safe and effective.

Purpose

The purpose of this TIR is to provide guidance on the development of safety cases for the design of a medical device. It is intended primarily for product developers, quality assurance, regulatory reviewers and auditors - anyone who requires a clear and complete story regarding the safety of a medical device's design.

Even though drug delivery devices have been primarily used within examples shown, the same definitions and approach can be used for any medical device.

Document History

AAMI TIR38
January 1, 2019
Medical device safety assurance case report guidance
This TIR is a safety case development reference for medical device design. The TIR is intended to provide a framework within which experience, insight, and judgment are applied systematically to...
January 1, 2014
Medical device safety assurance case report guidance
This TIR is a safety case development reference for medical device design. The TIR is intended to provide a framework within which experience, insight, and judgment are applied systematically to...

References

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