The development of medical device, hardware and software is strongly linked to risk management and compliance with safety requirements according to international standards.
Whether you need consultancy, support or training – we support your team with our expertise in safe product design.
With our many years of experience in hardware and software development in medical technology, we support you in meeting the legal requirements for medical devices and in launching your products on the market in both the EU and the USA.
The Lorit Consultancy team has extensive practical experience with the following standards in the medical device industry: IEC 60601 (Safety requirements for medical electrical equipment and in medical systems), ISO 14971 (Medical devices – Application of risk management to medical devices), IEC 62366 (Application of usability engineering in medical devices), IEC 62304 (Medical device software – software life cycle processes) and AAMI TIR57 (Principles for medical device security – Risk Management).
Consulting & Support
- Risk management
- Requirements management
- Quality management
- Hardware and embedded software reviews
- Product architecture
- Failure mode and effect analysis (FMEA), fault tree analysis (FTA), failure mode and effect analysis (FMECA), hazard and operability (HAZOP)
- Preparation of all relevant work packages, reviews and reports
- Cybersecurity and usability
- Reliability engineering
Our training takes place either online or live and can be delivered in English or German.
We are also happy to work with your organisation to develop bespoke and cost-effective in-house training to meet your requirements in terms of dates, delivery and content.
Companies all over the world rely on our extensive knowledge in safety-relevant industries when developing their products.
”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.”