sitem-insel AG

M5 - Quality Management

Module leader: Markus Wipf, AXXOS GmbH



Date and Credits

Start: 14.09.2020

Duration: 14 Weeks

5 ECTS

Module 5 provides a comprehensive and practical study of quality assurance as it pertains to medical devices.


Learning objectives

  • To develop a basic understanding of the requirements for quality management
  • To know the structure of Quality Management Standards (9001 / 13485 / MDSAP / FDA)
  • To understand the process approach and to know how to develop written procedures
  • To know the main procedures of  a Quality management system and to know how a quality management system is structured

Learning content

  • Design controls and Writing standard operating procedures (SOPs) for training
  • Design verification and Validation
  • Document controls
  • CAPA, complaints and non-confirming products
  • Production controls
  • Audits and reviews