Markus Wipf


  • 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 AG


  • > 5 years top management of a company with more than 100 employees
  • > 20 years management responsibility in different positions
  • > 25 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.)   


  • Develop QM-Systems according EN9001 and 13485, 21CFR820 (FDA), MDD and MDR
  • 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
  • Technical due diligence analysis in aerger and acqusition situations for both sides


  • 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