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AAMI TIR38
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AAMI TIR38 2014 Edition, January 1, 2014 Medical device safety assurance case report guidance
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Description / Abstract:
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 "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.
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 "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.