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