Medical Engineering

Let us develop your product! From the moment your idea is born all the way to production!

As provider of development services, we develop complete medical devices, electronic components and firmware. The development takes place in the customer process or in our own ISO 13485 certified process. The field of medical products starts with portable devices and ends with complex systems such as medical robots and implants. These also meet the highest requirements such as risk class III (MDR) and software safety class C (IEC 62304).

In addition, we advise our customers on usability, risk management and standard-compliant documentation. We excel in the timely provision of premium hardware and software as well as documentation suitable for successful approval in Europe and the USA.

Engineering Services

We develop complete medical devices for you in the fields of hardware, software and housing construction, including the documentation required for approval.

  • We design the HMI for maximum usability.
  • The hardware meets the high requirements of EN 60601-1.
    • The reliability of portable devices is based on our experience in battery management and radio interfaces.
  • The software meets the software safety classes up to C.
    • The platforms range from compact embedded boards through Linux-based boards and PCs to medical apps.
  • The mechanical design realizes protection classes up to IP69K.
  • We implement functional safety (single fault safety) consistently and transparently.
  • The approvals include CE for medical products, FDA and UL.
  • For the implementation of communication solutions in hospitals, we have many years of experience with HIS (Hospital Information System, HL 7, GDT) and all standard communication protocols.
  • We analyze IT risks competently and certified according to ONR 49003 and implement solutions for Cyber Security process-compliant.

Consulting

  • Set-up and maintenance of development processes
  • Risk management in accordance with EN ISO 14971
  • Preparation and professional examination of technical concepts, in particular for functional safety and IT security
  • Assessment and revision of documents relevant for approval

Developed Products

For our customers, we have developed both diagnostic and therapeutic medical products for the most diverse areas of medical technology. You will find our expertise in anything involving electronic technology: In the OR, on intensive care units, in medical practices, with physiotherapists and in the homecare sector. In infusion and medication pumps, electrostimulators, operating tables, surgical lamps, endoscopy systems. In small, mobile devices or large equipment.

Standards and Directives

We are certified to EN ISO 13485 and work to the following standards and directives among others

  • Medical Devices Directive (Council Directive 93/42/EEC; amended by 2007/47/EC); 21 CFR Part 820; Medical Device Regulation (EU) 2017/745
  • IEC 60601-1: “Medical electrical equipment – Part 1: General requirements for basic safety and essential performance”
  • IEC 60601-2-x: “Particular requirements for the basic safety of medical equipment”, particular standards
  • IEC 62366: “Medical devices - Application of usability engineering to medical devices”
  • IEC 62304: “Medical device software - Software life-cycle processes”
  • EN ISO 14971: “Medical devices - Application of risk management to medical devices”
  • IEC 62133: “Secondary cells and batteries containing alkaline or other non-acid electrolytes – Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications”
  • IEC 61508: “Functional safety of electrical/electronic/programmable electronic safety-related systems”
  • Guidances for FDA
    • “Premarket Submissions for Management of Cybersecurity in Medical Devices”
    • “Postmarket Management of Cybersecurity in Medical Devices”

 

 

Who to contact

Dr. Kai Borgwarth

Head of Business Unit Medical Engineering
Marketing and Sales

Member of the Management Board

Fon:    +49 761 479799-677
Mobile: +49 151 4223 2542
k.borgwarth@embeX.de

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Contact

Tel.: +49 761 479799-677
k.borgwarth@embeX.de