AAMI TIR57

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.

Our services

Consultancy & Support:

Security analysis, evaluation and control
Definition of security solutions
Post-market monitoring

Training:

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.

Cybersecurity Medical Devices Trainer

To the profile

Alastair Walker

Owner/Consultant

Testimonials

Companies around the world rely on our extensive knowledge in safety-relevant industries when developing their products.

In summary; very useful, the recommendations/observations are recognisable and the report will help steer future 62304 compliance efforts.
In addition, the report also satisfied our external stakeholders.

Phil Cooley – Quality Manager, Bond Digital Health Ltd

Thank you, for a terrific course!
The trainer was extremely knowledgeable about the material, and made the content very easily digestible, even the more challenging bits. I am very satisfied.

Rhyse Jaeschke – Manager, System Verification & Validation Ultrasound R&D, Philips Healthtech

With Lorit Consultancy we have found an extremely reliable partner who sees the big picture. Through their Functional Safety Engineering (ISO 26262) competence, we enjoy support at the highest level within our automotive product development. Remarkable is the smooth integration into our internal development team and the always professional & uncomplicated communication. We look forward to many more joint projects!

Harald Sporer – Senior Project Manager, Automotive Sense & Control, Infineon

“It was really a very helpful and excellent training!”

Marco Augustin – Quality and Software Manager, Occyo

”Lorit Consultancy´s support was instrumental in helping us achieve compliance in IEC-62304/ 82304 and ISO 14971 for our software-as-a-medical-device product.”
Ju Zhang – Founder, CEO Formus Labs

“Plexus has used the services of Lorit Consultancy in relation to a new healthcare project where insights into ISO 14971 and IEC 60601-1 international standards was needed. We have been very impressed with the quality of knowledge within Lorit and the quality of documentation and deliverable, and we look forward to continuing to partner with Lorit in the future.”
John Simpson – Senior Manager, Engineering Plexus

“Lorit Consultancy gave us excellent support in defining the requirements and implementing the BS EN 62304 document structure for our first product.”
Selly Saini – CEO Inside Biometrics

“Lorit Consultancy provided a professional and efficient service in defining regulatory requirements for both new developments and legacy products.”
Alastair Mutch – VP Research and Development, Diagnostics Cardiology Spacelabs Healthcare

“Lorit Consultancy gave us great support when guiding us through the process of hardware metric generation as defined in ISO 26262. Providing both the FMEDAs and training on the use of them.”
Geoff Owen Protean

“Very well executed, very helpful. Thank you for your time and expertise.”
Senior Electronics Engineer

“Essential for my job. Reduced my fear of 60601.”
Senior Mechanical Engineer

“It’s great to have the opportunity to receive this training from somebody who is obviously an expert in the topic and understands the practical implementation.”
Senior Design Assurance Engineer

“Excellent course and very pragmatic approach on implementing compliance.”
Senior Software Engineer

“The instructor was extremely engaging and clearly had excellent knowledge of the material.”
Innovation Agent