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 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.

 

ISO 14971 Trainer

Dijaz Maric

Quality Management & Reliability Engineering Consultant

Gerrit Steinöcker

Functional Safety Consultant

Testimonials

”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