Florian Fuchs

f.fuchsnoSpam@axxos.noSpamch

  • Diploma as Design Engineer
  • Mechanical Engineer with specialization in lightweight and biomechanical engineering
  • Medica device specific trainings (R&D; quality management, risk management)


Senior Consultant at Axxos AG since 2021

Experience

  • > 15 years of in different positions within the medical device field
  • > 10 years in biomechanical- and structural testing
  • > 8 years quality management systems for test laboratories (ISO 17025) in the medical device field
  • > 8 years of applied research in the field of biomechanics
  • 4 years management and leadership experience

Projects

  • Development, installation and qualification of testmethods for medical devices in accordance to ISO 17025 requirements
  • International transfer of test laboratories including all aspects of quality managment (re-Qualification/Validation, process optimizations) following ISO 17025 requirements and integration into ISO 13485 environment
  • Development of clinically relevant test methods for the proof of safety and effectiveness of medical devices for international regulatory clearance
  • Qualification of test laboratories and corresponding infrastructure
  • Development of processes for medical device verification and integration into R&D and life cycle management
  • Remediation projects in risk management (ISO 14971) and MDR
  • Product development of medical devices (surgical instruments, hip, knee and spine implants)
  • Lecturing to the topics of device testing and biomechanics

 

Skills

  • Medical devices: Orthopedics (Hip, Knee), Spine, Dental
  • Mechanical engineering
  • Medical device testing (ISO 14801, ASTM F1717, etc.) for international regulatory submissions (CE and 510k)
  • Development of clinically relevant test methods
  • Medical device development (V-model, FDA Design Control)
  • Applied research in medical devices
  • Development and installation of test laboratories and corresponding quality management systems (ISO 17025)
  • Documentation within the development process of medical devices, especially product verification and proof of safety and effectiveness

My personal scrabble - is coming soon