ISO 21448

ISO 21448 Consultancy & Training

For the team at Lorit Consultancy, safety comes first. The safety standard for road vehicles ISO 21448: Safety of the Intended Functionality (SOTIF) is consequently part of our range of services.

Whether you need consultancy, support or training – we support your team with our expertise in safe product design.

About ISO 21448

The safety of road vehicles is of key importance to the automotive industry. The ISO 21448 safety standard focuses on the avoidance of unreasonable risks and provides guidance on measures to ensure the safety of the intended functionality (SOTIF).

Hazards can be caused by reasonably foreseeable misuse or abuse of the intended functionality, among other things. Furthermore, the combination with other functions at vehicle level should also be considered as sources of hazards.

ISO 21448 distinction from ISO 26262

While SOTIF deals with the safety of the intended functionality, the standard ISO 26262 “Road vehicles – Functional safety” describes the general safety of a system – i.e. the reduction of risk by identifying and correcting failures in the system.

ISO 21448 is used to ensure safety in the context of functionality and covers hazards that occur without failures in the system. Especially in the increasingly important field of automated systems and artificial intelligence, SOTIF plays an essential role.

Our services

Consultancy & Support:

Consultancy and training ISO 21448
SOTIF with regard to usability
Consultancy on SOTIF for planned AI application

Training:

We offer (online) training courses that can be customised to meet your requirements in terms of date, format and content.

As part of our ISO 26262 course, we also go into detail about ISO 21448 SOTIF and highlight the differences between the two standards. Furthermore, you learn the basics of ISO 26262 with working examples, team exercises and our industry knowledge and experience.

ISO 26262 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.

Lorit Consultancy guided us through the intricacies of security regulations for medical devices in no time. We received concrete and comprehensive answers to questions we had been unable to find answers to for some time. Now, we can go to the market faster.

Natalia Kazankova – Senior Product Marketing Manager, Code Intelligence

As a leading medical device manufacturer, we greatly benefited from Lorit Consultancy`s services. The training always has effective combination of theory with practical insights, what is essential for our medical device development/manufacturing. The trainers were exceptional, simplifying complex concepts and engaging us with interactive discussion and case studies. Training has enhanced our teams capability of ensuring our products meet the highest standards.

We sincerely appreciate the professionalism and expertise of the Lorit Consultancy team. Their commitment to excellence has profoundly impacted our work. Thank you for an outstanding training experience.

Vladislavs Pavlovs – Laser and Electronic Components Development Department, CeramOptec GmbH

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

Essential for my job. Reduced my fear of 60601.

Senior Mechanical Engineer

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

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

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

Excellent course and very pragmatic approach on implementing compliance.

Senior Software Engineer

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

The instructor was extremely engaging and clearly had excellent knowledge of the material.

Innovation Agent