Medical Devices

Consultancy & Training

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.

Our expertise bringing you safely to success

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.

Additionally, as EU Representative, we support you as your interface to the competent authority, informing you of the current market position and supporting your technical file management.

Standards Medical Device Industry

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), IEC 61010 (Safety requirements for electrical equipment for measurement, control, and laboratory use), ISO 14971 (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), ISO 13485 (Quality management systems for medical devices) and Medical Device Cybersecurity (Principles for medical device security – Risk Management).

EC Authorized Representative

IEC 61010

ISO 13485

IEC 62304

IEC 60601

IEC 62366

ISO 14971

Cybersecurity Medical Devices

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
EU Representative

Training

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.

Testimonials

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

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

“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

CONTACT

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We look forward to hearing from you.