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 highly demanding development projects is probably the business unit's most important competence.
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.
- 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 and ONR 49003. Thus, the implemented solutions for cyber 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.
- The verification & validation is carried out efficiently and automatised in a specialised department.
- The approvals include CE for medical products, FDA and UL.
- Products and production equipment can be developed according to GAMP® 5.
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.
Communication inside the OR
You benefit from synergy effects in in-vitro-diagnostics (ivD), point-of-care technologies (POCT) and laboratory automation in general. We combine our know-how in the embeX Industrial and Process Automation with that in the Medical Devices Directives (MDR). We have developed control systems and control units for measurement techniques, sensor technology and actuator technology in small tabletop units as well as in large systems and thus, met the requirements of GAMP® 5.
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
- Medical Devices Directive (MDD, Council Directive 93/42/EEC; amended by 2007/47/EC); 21 CFR Part 820
- 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 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”