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.