Daniel Helbling


  • MSc in Sport and Moving Science
  • CAS Paralegal
  • CAS Business Administration
  • Several trainings in quality management, project management
    and complaint handling
  • IRCA certified lead auditor ISO 13485:2016

Senior Consultant at Axxos AG since 2018


  • > 15 years in quality management of medical device industry
  • > 8 years at a market authorization holder of medical devices in the area of complaint management and vigilance
  • 3 years as quality representative at a contract manufacturer for pharmaceutical, medical device and in-vitro-diagnostic companies
  • > 7 years management responsibility in different positions within quality (max. 26 employees)
  • 2 years part of management team of a company with more than 100 employees


  • Successful design and implementation of quality processes using different quality management softwares (TrackWise, Pilgrim, SAP QIM)
  • Establish, maintain and optimize QM-systems according to ISO 9001 / EN 9100 and ISO 13485, 21CFR820 (FDA) and MDD / MDR
  • Complaint management, reporting to and communication with competent authorities
  • International, multi-site optimization projects for the complaint handling, CAPA, change process
  • FDA readiness, preparation for and translation at FDA inspections (front- and backroom)
  • Internal and supplier audits according to ISO 9001, ISO 13485 and 21CFR820 (FDA requirements)


  • Medical devices (orthopedic and traumatological implants and instruments, therapeutic devices)
  • Combination products (inhalers, autoinjectors)
  • In-vitro-diagnostic products (cuvettes, vials, consumables)
  • Materials (metals and polymers)
  • Complaint handling / root cause analysis / communication with competent authorities
  • Quality management processes e.g. change control, document control, nonconformity, CAPA, management review
  • System (QMS), process and supplier audits
  • FDA inspection support

My personal scrabble