AAMI TIR 38 pdf free download

AAMI TIR 38 pdf free download.Medical device safety assurance case report guidance.
5 Regulatory context
Safety Cases have since been adapted for use by high-risk industries such as rail service, nuclear, and defense. The UK Defence Standard 00-56 requires the development and maintenance of Safety Cases over the product development lifecycle: the submission and acceptance of the Safety Case is an integral part of the Ministry’s evaluation of program progress.
However, it Is important to note regulatory differences between other high-nsk industries and the medical device industry. These differences drive subtle but important differences in the breadth and depth of documentation that is provided in an assurance case. Assurance cases can only be effective communication tools if the audience’s needs are well understood, and medical product regulators have different needs than Ministnes of Defence.
For example, regardless of industry, one of the contributing factors to product safety is that its design and testing was performed by qualified personnel. Evidence of training records therefore are part of a defense “submission. However, the FDA and various Ministries of Heatth do not require this level of detail, as training records are not typically part of a medical device submission. Operators must be trained as part of design controls, the training must be documented. and those records are subject to audit, but are not provided in a substantial equivalence-based regulatory submission. This difference in level of detail is one of the distinguishing features of a medical device safety case as compared to Classic Safety Cases in other industries.
6 Safety case model for a generic medical device
Model obiective
The objective of the safety case model proposed in this TIR is to provide a starting point for your safety case and explain one methodology for development of a convincing safety case The model is intended only as a framework under which the developer can create a safety case unique to their device. After familiarizing yourself with the suggested top-level cLaims/arguments and evidence characteristics described within the model, you will need to carefully implement processes and analysis to produce the safety case for your particular device. The safety case for a medical device intended for market will be much more detailed and thorough than the information presented within the model. Additionally, the safety case model presented is limited to demonstrating that the design of the device is adequately safe. As such, the concepts presented are related to the design of the device only and do not extend to the construction, installation, or manufacturing of the medical device.
6.2 Safety case introduction
A safety case consists of a structured argument, supported by a body of evidence that provides a compelling. comprehensible and valid case that the medical device is safe I or its intended use (e.g. for use on intended patient populations, by intended users, within intended environments of use). Safety cases are unique to individual products and are dependent on individual product requirements, hazards, design. and documentation.
The safety case is fundamentally grounded in safety engineering practice and principles. If you have already implemented an adequate safety engineering management system, then the creation of a safety case should be a natural extension of your existing activities.
The generation of your safety case should begin early in the design and development process and should be updated often as the design reaches its final stage.
Main elements of a safety case are described within the definition section. Included below is a general schematic of the progression of a safety case with each of the elements in a diagrammatic format. As is noted in section 15, Styles of safety case notation, we recommend the use of multi iormat safety cases. However, the goal of this TIR is not the format. Rather, the goal of this TIR is to explain a preferred argumentation pattern.AAMI TIR 38 pdf download.