Main Qualifications are:
- Auditor according to ISO 13485:2007
- Special Know-how at national and international standards
- Legislation for MDR, 510(k), Japan, Brasil/Mexico/Peru
- CAPA-Management
- Risk Management according to ISO 14971:2019
- Usability according to IEC 62366:2015
- Product- and Process-FMEA
- Cybersecurity
- Qualification and Validation of Production Processes
- Know-how regarding Sterilisation processes for medical devices
- Know-how regarding Biocompatibility at medical applications