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, firmware, and mechanical construction. 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), software safety class C (IEC 62304), and cyber security. Mastering the complexity of demanding development projects and ensuring safety through cyber security are probably the most important competencies of the business unit.
In addition, we advise our customers on risk management, standard-compliant documentation and usability. We excel in the timely provision of premium hardware and software as well as documentation suitable for successful approval in Europe and the USA. On request we transfer our know-how and the norm-compliant processes to our customers.
We develop complete medical devices for you in the fields of hardware, software and housing construction, including the documentation required for approval.
- From use cases, our system engineering competently creates the functional product requirements.
- 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.
- We manage IT risks competently and certified according to ISO 31000. Thus, the implemented solutions for cyber security and the combination of safety&security are process-compliant.
- 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.
- For the Internet of Medical Things (IoMT) we develop complete devices ready for approval and implement interfaces.
- The verification & validation is carried out efficiently and automatised in a specialised department.
- The approvals include CE for medical products, FDA and UL.
- Lab and production equipment can be developed according to GAMP® 5.
- 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 cybersecurity including the combination safety&security
- Assessment and revision of documents relevant for approval
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, gateways, electrostimulators, operating tables, surgical lamps, endoscopy systems. In small, mobile devices or large equipment.
embeX masters the implementation of the following communication standard:
- HL7 (Connectivity with HIS: Hospital Information System)
In order to realize direct communication between medical devices in the operating room of the future, industrial companies, clinics and research institutions have joined forces in the association OR.NET e.V. The result is the open standard ISO/IEEE 11073 “Service-oriented Device Connectivity” (SDC), which defines a system architecture for networking of medical devices and IT systems. This standard has now also been recognized by the FDA as a “recognized consensus standard”.
The detailing of the standard for special device classes is carried out in the PoCSpec project, in which embeX is the only development service provider and is therefore prepared for the implementation of corresponding development projects.
Standards and Directives
We are certified to EN ISO 13485 and work to the following standards and directives among others
- Medical Device Regulation (MDR, EU) 2017/745
- FDA 21 CFR Part 820
- 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”
- IEC 61010: “Safety requirements for electrical equipment for measurement, control, and laboratory use”
- 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 61508: “Functional safety of electrical/electronic/programmable electronic safety-related systems”
- Guidance by Medical Device Certification Group
- MDCG 2019-16: “Guidance on Cybersecurity”
- Guidances by FDA
- ISPE GAMP® 5 Guide: “A Risk-Based Approach to Compliant GxP Computerized Systems”