AAMI TIR57 Consultancy & Training
Lorit Consultancy’s team has years of experience in risk management in the context of medical device, hardware and software development. The Technical Information Report (TIR) 57 of the Association for the Advancement of Medical Instrumentation (AAMI) is an important guidance here for methods to carry out cybersecurity analyses.
Whether you need consultancy, support or training – we support your team with our expertise in safe product design.
Cybersecurity risk management
There are numerous standards and guidelines for the medical device industry, but currently only one document that combines risk management with cybersecurity: AAMI TIR57: Principles for medical device security – Risk Management. The report provides guidance to companies on identifying, assessing, controlling and monitoring IT security risks.
AAMI TIR57 and other standards
As a guidance document for the ISO 14971 risk management standard, the structures of both documents mirror each other. The TIR57 guidance is thus based on ISO 14971, but the focus is on threat analyses. In this context, valuable practical examples are given on how companies can minimise threats to their products.
TIR57 is also linked to the technical report TIR97 Principles for medical device security – Postmarket risk management for device manufacturers – a guide for security risk management after the launch of a product.
Consultancy & Support:
- Security analysis, evaluation and control
- Definition of security solutions
- Post-market monitoring
We offer (online) training courses that can be customised to meet your requirements in terms of date, format and content.
Our cybersecurity course for medical devices relates to cybersecurity in general, with references to international standards such as ISO 14971, AAMI TIR 57 and NIST. In addition to a comprehensive overview, we also provide detailed insights into the areas of analysis and methods.
In this way, you learn how cybersecurity becomes an integral part of your projects and benefit from our industry knowledge and experience.