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 course that can be customised to meet your requirements in terms of date, schedule and content.
Learn the basics of ISO 14971 with working examples, team exercises and our industry knowledge and experience.
Learn the basics of the standard in our ISO 14971 course with working examples, team exercises and our industry knowledge and experience. You get an overview of risk management and assessment techniques, an understanding of how to apply the standard with a detailed insight and examples of risk analysis techniques.
In addition, we address the topic of cybersecurity and AAMI TIR57.