target group
The certificate course is aimed at employees in quality management who are responsible for the implementation of the specific requirements in the development, manufacture and monitoring of medical devices and who want to bring their specialist knowledge up to date, as well as at managing directors or at QM Specialists who want to switch to medical technology from other industries.
content
Armed for the diverse challenges in quality management: The certificate course provides the participants with a comprehensive portfolio of knowledge and tools - not only to find out which specifications exist, but also how they can be implemented in the company.
Module 2 goes into more detail on the development of medical devices - from biocompatibility to validations.
Topic overview & dates
Module 2 - Product Realization
06/30/2022 Biocompatibility and biological safety of medical devices
07/12/2022 Clinical evaluation and clinical testing of medical devices
07/27/2022 Design Control
09/13/2022 Validation of processes in the medical device industry
09/20/2022 Cleaning validations within the manufacturing processes of medical devices
04.10.2022 Placing medical devices on the market
Test.
exam and graduation
After the course, the technical knowledge and skills acquired are tested in writing. Please register for the exam via our appointment calendar.
After passing the exam in all three modules, the participant receives a certificate issued by MedicalMountains GmbH.
a notice
The modules can be booked individually. If these are attended within 2 years, you will receive a certificate. If you book all three modules at once, you will receive a special price.
investment
Investment EUR 2,800.00 plus VAT plus EUR 100.00 examination fee
You can use the following links to book additional modules or the entire certificate course:
Quality manager medical technology module 1
Quality manager medical technology module 3
Overall quality manager for medical technology
Funding Opportunity
ESF funding is possible. More information can be found here .
KONTAKT:
Max-Planck-Straße 17, TuttlingenBeruflichen Bildungsstätte Tuttlingen & Online
