IVD Expert and Regulatory Affairs Manager with 15 years experience in IVDs and Medical Devices.

Senior IVD Expert and Regulatory Affairs Manager with 15 years experience in IVDs and Medical Devices. 

• Project Leader and Team Leader
• IVDR / MDR / FDA
• Performance Studies
• Technical Documentation and Marked Authorization
•  Communication with Notified Bodies and National Competent Authorities
• Post Market Survillance, Vigilance

Spezialized in:

• Market Authorization in US; Europe; Asia
• Biocomp; Toxicology; Medical Writing; Technical Writing;  Performance Evaluation

Trained in the following Standards and Guidances:

• ISO 13485 (QMS Systems for Medical Devices)
• ISO 14971 (Risk Management)
• ISO 10993-1 (biocompatibility)
• DIN EN ISO 11135 (sterilization with ethylene oxide); DIN EN ISO 11137  (sterilization with radiation); DIN EN ISO 17665 (sterilization with moist heat); DIN EN 556-1 (labelling of sterile devices); DIN EN ISO 14937 (general requirements for the characterization of sterilizing agents and for the development, validation, and routine control of sterilization processes)
• DIN EN ISO 11607-2 (requirements for medical-device packaging, including validation of the packaging processes)
• ISO 17664-2:2021 (Reprocessing of reusable Instruments)
• IEC 60601-1 (el. Safety); IEC 60601-1-2 (EMC)
• IEC 62366-1 (Usability)
• IEC 62304 (software)
• ISO 15223-1 (symbols)