Monika Schmid

m.schmidnoSpam@axxos.noSpamch

  • MSc Human Movement Sciences, Major in Biomechanics, ETH Zurich
  • Teaching Diploma in Biology, ETH Zurich
  • CAS QM/RA Medical Engineering, SAQ Qualicon
  • Design control, AAMI (Association for the Advancement of Medical Instrumentation)


Senior Consultant at Axxos GmbH since 2021

Experience

  • 5 years in medical device industry (dental implants und heart valves)
  • 3 years of verification and biomechanical research including laboratory practice
  • 2 years of post-market surveillance and field actions
  • Risk management for medical devices utilizing animal tissues and their derivatives
  • Clinical evaluation according to MEDDEV 2.7/1 revision 4
  • Laws and standards relevant to the medical device industry

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
  • 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 and heart valves)
  • Clinical evaluation according to MEDDEV 2.7/1 revision 4

My personal scrabble - is coming soon