With each apparatus used in the medical technology field, the user's safety and the reliability of the application are of prime importance. This demands a development considering the required norms, design methods, risks and certificates.
A detailed and complete documentation is given just as much weight as the entire traceability and the compliance with the predefined development processes. Each product undergoes stringent verification and validation at the various development stages before it is allowed for certification.
The competences for this field are:
Development in accordance with the norms for medical products ISO 13485
Carrying out of risk management in accordance with ISO 14971 (FMEA, FTA)