Schlagwörter
Fmea
Risikoanalyse
21 Cfr
Berechnungen
Iec 62304
Iso 13485
ISO 14971
Projektmanagement
Produkttest
Qualitätsmanagement
Skills
- Quality assurance in accordance with the latest published European or international recommendations ( e.g. EN ISO 13485, EN ISO 14971, IEC 80002,EN IEC 62304 and GMP for Medical Devices -FDA 21 CFR 820).
- Risk analysis of clinical protocols, medical devices, software (FMEA).
- Testing (acceptance, commissioning, periodical) of medical devices in accordance with the latest published European or international recommendations.
- FEA and MB computer simulations and analysis of material models under different impact conditions.
- Internal and external project coordination
Projekthistorie
Upon request
Reisebereitschaft
Verfügbar in den Ländern
Deutschland
Free