Markus Wipf

m.wipfnoSpam@axxos.noSpamch

    • Master of science (mechanical engineer)
    • Master of economics
    • Master of human resources management
    • Several educations in quality management
      (Medical Device Regulation, Europe and USA, FDA/GMP)
    • IRCA certified Lead auditor ISO 13485:2016

    CEO & Owner of Axxos GmbH

      Experience

      • > 5 years top management of a company with more than 100 employees
      • > 10 years management responsibility in different positions
      • > 20 years quality management responsibility medical devices (ISO, GMP)
      • > 10 years production skills
      • > 5 years development and construction experience
      • 5 years in a human resources manager position
      • More than 200 internal and external audits as lead auditor (ISO 13485 and FDA)

      Since 2006 senior consultant for medical device industry (implants, active devices, etc.)   

      Projects

      • Develop QM-Systems according EN9001 and 13485, RL 93/42 EWG (MDD), 820 CFR (FDA)
      • Successful certification and recertification with more than 20 companies
      • Establish and implement validation concepts in various MedTech-companies
      • FDA readiness, compliance and guidance through FDA investigations
      • Establish and maintain technical documentations for CE-mark
      • Internal and supplier auditing according ISO 9001, 13485 and FDA requirements
      • Establishing custom made implant procedure; from X-ray/CT to implant
      • Lead in more than 10 FDA inspections
      • Coaching more than 15 start-up companies in quality management and product certification
      • Giving public lectures about various topics of the medical device industry

      Skills

      • Medical Devices (orthopedic, spine and ophthalmic implants and instruments, active devices with and without software, therapeutic devices, dental systems)
      • Materials (metals and polymers)
      • Manufacturing and cleaning procedures
      • Quality management and validation of equipment, production and inspection processes
      • Cleanliness validation and biocompatibility testing
      • Quality system, process and supplier auditing
      • FDA Investigation: pre and post audit activities as CAPA plans and communication to FDA
      • Spontaneous projects to achieve and/or maintain compliance
      • Lead and coach change management processes
      • Human resources management and Swiss labour law

      My personal scrabble