Swiss Institute for Translational and Entrepreneurial Medicine (sitem-insel)

Standalone Modules

Module 5 - Quality Management

Content

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

Learning objectives

In this module, participants learn to develop a basic understanding of the requirements for quality management, know the structure of Quality Management Standards (9001 / 13485 / MDSAP / FDA) and the main procedures of a quality management system and how it is structured, and understand the process approach and how written procedures are developed.

Learning content

Module 5 covers design controls and writing standard operating procdures (SOPs) for training, design verification and validation, document controls, CAPA, complaints and non-confirming products, production controls, and audits and reviews.

Start & Duration

Module 5 starts in September each year.
The completion takes approximately 12 weeks.

Credits

5 ECTS

Fee

The cost of this standalone module is 5250.– SFr.

Reference

03.005

Module Leaders

CEO and Owner of AXXOS

Markus Wipf

Markus Wipf has has been working in the medical device area since 1995, when he founded AXXOS in 2007. Today, with Markus as CEO, AXXOS provides quality management and conformity assessment services, has four certified auditors to perform both, internal and supplier audits according ISO or FDA requirements, compiles clinical evaluation reports and establishes technical files for the CE marking of medical devices.