The following services can be performed:

  • Working on both sides of the Quality Management System table
    • Setting up / Improving of a QMS (ISO-13485 / CMMi)
      Lean to fit in your organization
      According to my proven way-of-working
    • Auditing of a QMS on compliancy with the ISO-13485 / CMMi
      As a contractor for the well known Notified Body: DEKRA
      Via Trial Audits to prepare you for a real Notified Body audit
  • Implementing Software development procedures 
    • According to the Software Life Cycle Medical Devices (IEC-62304)
    • According to the CMMi-model
    • In case software is becoming more important to your product
  • Creating a GUI WebPortal for easy access to the QMS
  • Support on CE / Technical File 
  • Performing Internal Audits
    • As an external  expert performing the Internal Audits for you
    • With the external view to your internal processes
  • Performing Supplier Audits 
  • Quality Assurance 
  • Setting-up a metrics program
    • Business Balance ScoreCard
    • Key Performance Indicators
  • Training
    • Training is a standard part of my work
    • Stand alone training is possible
    • Some trainings modules are part of the program of Mikrocentrum
  • Coaching