Consultancy in Functional and Non-Functional Safety & Compliance

Functional Safety and Product Safety Consultancy

Our consultancy services provide expert guidance across both functional safety and non-functional comprehensive product safety, helping companies from various industries navigate the complexities of safety standards and regulations.

Functional Safety ensures that a product operates reliably and safely, even in the event of malfunctions, by addressing safety-critical systems. Where functional safety is key, our consultants work closely with clients to ensure that their systems are designed, implemented, and tested to meet stringent safety standards such as ISO 26262 for automotive functional safety and IEC 62304 for medical device software.

Our expertise extends well beyond functional to comprehensive product safety, addressing safety concerns that are not directly tied to functionality but are equally vital. This includes electrical safety, mechanical integrity, and environmental risks, governed by standards such as IEC 60601 for medical electrical equipment, IEC 60664 for insulation coordination and IEC 61010 for laboratory and measurement equipment.

By ensuring compliance with these safety standards but not being limited by the above, we help you safeguard your products from risks posed by environmental conditions, user interactions, and operational stresses, ensuring they meet the global safety regulations required for market approval.

Regulatory Compliance Support

Successfully navigating the complex landscape of regulatory compliance is essential to bringing products to market safely and efficiently. Our regulatory consultancy services are designed to guide you through the ever-evolving regulatory frameworks that govern your industry, ensuring that your products meet all necessary safety, environmental, and performance standards.

Our team of experts provides tailored regulatory consulting across a wide range of regulations, helping you achieve compliance with critical frameworks such as ISO 13485 for medical devices, IATF 16949 for the automotive sector, and FDA approvals for those entering the U.S. market. Whether your product requires a 510(k) submission, CE marking, or compliance with the latest Medical Device Regulation (MDR), we ensure that all necessary documentation and technical standards are met at each stage of your product’s lifecycle.

As your EU Authorized Representative, we support companies outside the EU by managing regulatory documentation, liaising with authorities, and ensuring your products meet all European directives. Our practical, hands-on approach minimizes compliance risks, streamlines approval processes, and ensures your products are market-ready.

Industries We Support in Ensuring Product Safety

Over the years, our team at Lorit Consultancy has supported a wide range of projects across multiple industries. From software safety in ambulatory ECG recorders to ADAS sensors in agricultural machinery and battery management systems in the automotive sector, we help our clients identify risks and establish sustainable safety strategies.

Medical Device Safety Consulting

Drawing on the experience as system, hardware and software engineers, our consultants provide practical strategies for smooth certification and swift market entry.

We support projects from pacemakers and blood glucose meters to stress-test systems and skin-condition monitoring apps, advising on the safety of medical electrical equipment (IEC 60601 and related standards) and Software as a Medical Device (SaMD).

Our team is actively involved in the ongoing development and revision of IEC 60601 and IEC 62304 within the respective committees, contributing practical expertise to the next generation of requirements.

Lorit expertise covers international regulatory submissions, including EU and UK MDR, FDA approvals, to facilitate smooth product launch in multiple regions.

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Automotive Functional Safety Consulting

Since its founding over a decade ago Lorit consultancy has been supporting the industry through our hands-on experience in automotive and embedded systems. Our services are built around functional safety, risk-based system design, quality management, and cybersecurity.

From the concept phase through to series production our team helps overlooking implementation and maintenance of your functional safety strategies and tactics.

Whether ISO 26262, IATF 16949, ISO 21448, or ISO/SAE 21434 – we support the teams across the globe in translating standards into practical, workable solutions for real development projects.

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Industrial Safety Consulting

Whenever safety-relevant challenges arise, our cross-industry team has been supporting a wide range of industrial sectors, including aviation and aerospace, railway, mining, agricultural machinery, and beyond.

In aviation and aerospace, we integrate system safety, software and hardware assurance, reliability engineering, and certification support across the entire development lifecycle, aligned with standards such as ARP 4754A and ARP 4761, as well as DO-178C and DO-254.

Furthermore, we support industrial projects with risk and safety analyses, requirements engineering, reliability assessments, and the application of relevant standards – always tailored to the specific operational and regulatory context.

Our Expertise in Safety and Compliance

Our team brings decades of experience across multiple sectors, applying knowledge from automotive, medical devices, and beyond. With over 10 years of experience as a team and over 35 years of cumulative knowledge, we offer unparalleled expertise in system and hardware development, risk analysis techniques and risk management, and functional safety management across diverse industries.

Whether working on complex automotive projects requiring compliance with ASIL D standards, helping medical device manufacturers implement safe IEC 60601 programmable electrical medical systems, or guiding through stringent safety assessment and audits protocols, our team delivers tailored solutions that align with best practices from various sectors.

By partnering with us, you gain access to a wealth of knowledge and hands-on experience that extends far beyond mere compliance. We enable you to address both functional and non-functional safety comprehensively, ensuring that your products not only meet regulatory requirements but also achieve the highest level of reliability and safety, safeguarding end users and enhancing your market position.

What sets us apart

Our mission is to empower businesses in the medical and automotive industries and beyond, offering expert consulting, tailored training, and long-term support to ensure successful development of innovative and safe products.

Customer-Centric Approach

We provide tailored support at any stage of the product lifecycle, ensuring solutions align with your unique requirements.

Flexible and Global Collaboration

We offer remote and on-site consulting, adapting to your schedule and location seamlessly.

Broad and Diverse Expertise

Our team covers multiple safety standards and industries, delivering comprehensive solutions for every challenge.

Proven Success and Client Loyalty

Trusted by key industry players, we have a strong track record and a growing base of returning clients.

Expertise in Functional and Non-Functional Safety

We address both safety aspects with deep knowledge of IEC 60601, ISO 26262, IEC 62304, and more.

Emphasis on Practical Solutions

We deliver actionable solutions that ensure compliance while supporting your business goals efficiently.

Testimonials

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

After working with several consultants, including some of the largest firms in the field, we were delighted to discover Lorit Consultancy. Their exceptional industrial expertise in functional safety, combined with their ability to tailor each training session to our specific needs and participants, has been invaluable. Their guidance has consistently enabled us to navigate complex challenges with confidence. We look forward to continuing our collaboration for many years to come.

Tilemachos Matiakis – Co-founder and technical director, Kenotom

Lorit provided exceptional expertise and guidance that helped improve our software development system. Their hands-on, collaborative approach made all the difference in achieving our compliance goals.

James Hamlyn – Quality & Regulatory Director, Skin Analytics

Our collaboration with LORIT started because we saw the need of bringing dedicated expertise for pushing the development of our projects in the right direction. The level of support showed by LORIT Team was high from the beginning, so we always felt confident in having a reliable partner, which could show availability whenever asked for.

We benefit from their support in different projects, covering diverse tasks (DFMEA Process, Risk Analysis Functional Safety ISO 13849) and although our documentation input was not ideal when starting the projects, they always found the understanding and adaptability to manage the challenges.

Mircea-Florin Onceriu – Project Manager / Lithium-Ion Battery Packs, VARTA Storage GmbH

Working with Lorit Consultancy has been an outstanding experience. The team supported us with the certification of our medical device and provided invaluable guidance throughout the entire process.

They are incredibly professional, highly reliable, and always focused on the client’s needs. Their deep technical know-how and hands-on experience were instrumental in helping us navigate complex regulatory requirements.

Everything about the collaboration was smooth and uncomplicated, and their support was consistently helpful. I’d highly recommend their services to anyone looking for expert guidance with a personal touch!

Tobias Baader – COO, Pixformance Sports GmbH

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

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

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

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