Experience

• 7 years in medical device industry (dental implants und heart valves)
• 3 years of verification and biomechanical research including laboratory practice
• 3 years of post-market surveillance and field actions
• 2 years clinical evaluation according to MEDDEV 2.7/1 revision 4 and EU2017/745 (MDR)
• Risk management for medical devices utilizing animal tissues and their derivatives
• Laws and standards relevant to the medical device industry
• Lecturer for clinical evaluation at SAQ Qualicon (www.saq-qualicon.com)

Projects

• Verification strategy and worst case definition of dental implants
• Update of post-market surveillance processes according to MDR
• Implementation of threshold values and trend evaluation based on statistical analysis for post-market surveillance
• Improvement of risk management for medical devices (dental implants and heart valves)
• Delivering In-house trainings
• Clinical evaluation according to MEDDEV 2.7/1 revision 4 and EU 2017/745 (MDR)
• Process owner of the Axxos update service for laws and standards

Skills

• Verification of safety and efficacy of medical devices
• Post-market surveillance of medical devices including trend evaluation and coordination of field actions
• Development and implementation of Standard Operating Procedures (SOP) in a highly regulated environment
• Systematic scientific literature search and evaluation
• Risk management according to ISO 14971
• Laboratory practice (wet lab and biomechanical laboratory)
• Knowledge of medical devices and their requirements (dental implants, heart valves and general orthopedic applications)
• Clinical evaluation according to MEDDEV 2.7/1 revision 4 and EU 2017/745 (MDR)