Peter Wehrli

p.wehrli@axxos.ch

 

  • MSc ETH (Diploma as Mech. Eng., major in Medical Engineering)
  • Executive MBA FH (General Management)
  • Several trainings in Project + Quality Management, GxP

 Senior Consultant at Axxos GmbH since 2019  

    Experience

    • > 20 years in medical device industry
    • > 18 years of experience as project leader
    • > 10 years in line management, thereof 7 years as Head of Development
    • Operating of clean rooms according to 14644-1
    • Extensive field experience in operating theatres
    • 1.5 years of experience as a teacher at a private school   

    Projects

    • Development of medical products of classes I, Ir, Is, IIa, IIb, III, mainly hip joint implants and surgical instruments, including successful market launch and maintenance
    • Fatigue tests of class III hip implants according to ISO 7206-2/4/6/8
    • Tribology of artificial hip joints
    • Development of products for surgical navigation
    • Project manager for electro-mechanical patch pumps for liquid drug delivery
    • Master’s thesis EMBA: ‚Bedarfsabklärung für eine Einzelsteril-Nachweismethode‘

      Skills

      • Life cycle management of medical devices
      • Development and maintainance of technical files
      • CE conformity assessment
      • Design verification and validation of medical products including application in the field
      • Definition of materials for medical devices (metals and plastics)
      • Reprocessing of medical devices (class Ir) according to ISO 17664
      • Cleaning, packaging and sterilisation of medical devices including transport validation (ISO 11607-1, -2, ISTA, ISO 11137-1, -2)
      • Behaviour in clean rooms and sterile areas (operating theatre)
      • Maintenance and optimization of Quality Management Systems according to ISO 9001 und ISO 13485, with focus on processes development/design, cleaning, packaging, sterilisation
      • Supplier audits according ISO 13485
      • Risk management according ISO 14971 and TR 24971
      • Labelling of medical products according ISO 15223-1, -2
      • Application of CAD software and FEM (finite element methods)

        My personal scrabble

        is coming soon ...