engineering the
embedded world

Lab Automation and In Vitro Diagnostics

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

As a development service provider, we develop complete devices for life science laboratories and in-vitro diagnostics (IVD) with all electronic components, firmware and mechanical parts. Our high competence in the integration of wired and wireless comunication interfaces, including the implementation of cybersecurity, should be emphasised.

We develop and integrate controls and operating units for measurement technology, sensor and actuator technology in small desktop devices as well as in large devices. Upon customer request, development is carried out according to ISO 13485, IVDR, 21 CFR 820 and GAMP® 5, and complete life science devices are produced at the customer's premises or by our established EMS network.

Engineering Services

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

  • System engineering lays the foundation for future-proof, modular systems.
  • Risks are managed according to EN ISO 14971.
  • We design the HMI for maximum usability.
  • The hardware meets the high requirements of EN 60601-1.
  • 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 realises protection classes up to IP69K.
  • Recquirements for medical products are met in all classes.
  • We implement functional safety (single fault safety) consistently and transparently.
  • We manage IT risks competently and certified according to ISO 31000 and implement solutions for cybersecurity competently.
  • 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 protocol such as WiFi and BLE.
  • For the Internet of Medical Things (IoMT) we develop complete devices ready for approval and implement cloud adapters.
  • For use in potentially explosive environments, we develop products based on intrinsically safe electronics and  take care of approval in worldwide sales markets.
  • The verification & validation is carried out efficiently and automatised in a specialised department.
  • The approvals include CE for in vitro diagnostics, medical products, FDA and UL.
  • In the product life cycle, we support the Product Security Incident Response Team (PSIRT) with coordinated services.
  • Products and production equipment can be developed according to GAMP® 5.

Communication

Frequently implemented interfaces are:

USB
WiFi, WLAN

Standards and Directives

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

  • In Vitro Diagnostic Medical Device Regulation IVDR (EU) 2017/746
  • Medical Device Regulation MDR (EU) 2017/745
  • Machinery Regulation (EU) 2023/1230
  • Machinery Directive 2006/42/EC
  • FDA 21 CFR Parts 11 and 820
  • IEC 62366: “Medical devices - Application of usability engineering to medical devices”
  • IEC 62304: “Medical device software - Software life-cycle processes”
  • ISO 14971: “Medical devices - Application of risk management to medical devices”
  • ISO 13849: “Safety of machinery - Safety-related parts of control systems”
  • EN IEC 62443: “Industrial communication networks - Network and system security”
  • IEC 81001-5-1: “Health software and health IT systems safety, effectiveness and security”
  • IEC 61010: “Safety requirements for electrical equipment for measurement, control, and laboratory use”
  • IEC 60601-1: “Medical electrical equipment – Part 1: General requirements for basic safety and essential performance”
  • IEC 60601-2: “Particular requirements for the basic safety of medical equipment”
  • ISPE GAMP® 5 Guide: “A Risk-Based Approach to Compliant GxP Computerized Systems”

Who to contact

Dr. Kai Borgwarth

Head of Business Unit Medical Engineering
Marketing and Sales

Fon:    +49 761 479799-677
Mobile: +49 151 4223 2542
kai.borgwarth(at)embeX.de

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Contact

Tel.: +49 761 479799-677
kai.borgwarth(at)embeX.de