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.
For medical technology, the German equavalent to the FDA, BfArM, has clarified: „Manufacturers and operators must increasingly focus on the IT security of networked medical devices: Cyber security is an essential prerequisite for medical device safety and patient protection”.
As a leading development service provider in embedded security and as the first company worldwide whose development process for functionally safe products was certified with the highest maturity level, embeX combines the know-how from both areas in the combination of Safety & Security.
We are certified to EN ISO 13485 and work to the following standards and directives among others