Your partner for functional safety and regulatory compliance.

Consultancy, Support, Training

Lorit Consultancy offers consultancy, support and (online) training in functional safety related projects in the medical and automotive sectors.

With our years of expertise with the complex exercise of international standards compliance, we support customers around the globe in the successful development of innovative and safe products.

Automotive

ISO 26262

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IEC 60664

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ISO 21448

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IATF 16949

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ISO/SAE 21434

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Requirements Management

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Medical Devices

IEC 60601

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IEC 62304

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IEC 61010

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IEC 62366

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Cyber­security Medical Devices

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ISO 14971

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ISO 13485

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EC Authorized Represen­tative

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Our next training dates

CourseISO 13485
Date24. Jul. / 1 day
TrainerVerena Wieser
Costs€700 / £650
File
CourseCybersecurity Automotive
Date25. Jul. / 1 Day
TrainerAlastair Walker
Costs€700 / £650
File
CourseUS Approval
Date29. Jul. / 1 Day
TrainerVerena Wieser
Costs€700/ £650
File
CourseISO 21448
Date30. Jul. / 1 Day
TrainerAlastair Walker
Costs€700 / £650

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

Philips

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

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