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.
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, medical robots, operating tables, surgical lamps, endoscopy systems. In small, mobile devices or large equipment.
embeX masters the implementation of the following communication standard:
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 recognised 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.
We are certified to EN ISO 13485 and work to the following standards and directives among others