Peter Wehrli

p.wehrlinoSpam@axxos.noSpamch

 

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

Head of Regulatory and Clinical Services
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 ...