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Armed for the diverse challenges in quality management: the certificate course provides participants with a comprehensive portfolio of knowledge and tools - not only to find out which specifications exist, but also how they can be implemented specifically in the company.
Module 1 conveys all the important basics of quality management in medical technology, risk management, technical documentation, DIN EN ISO 13485:2016 and 21 CFR 820 QSR. Module 2 goes into more detail on the development of medical devices - from biocompatibility to validations. Module 3 focuses on the monitoring of manufacturing processes, considering internal and supplier audits as well as post-market surveillance and vigilance.
target group
Employees in quality management who are responsible for the implementation of the specific requirements in the development, manufacture and monitoring of medical devices and want to bring their specialist knowledge up to date, as well as managing directors or QM specialists from other industries want to switch to medical technology.
Topic overview & dates
Module 1 - Quality Management
02/07/202 3 Quality management for medical devices according to DIN EN ISO 13485:2016
02/14/2023 The QM representative (QMR)
03/01/202 3 Technical documentation according to EU-MDR - structure and content
03/15/202 3 Quality management for medical devices according to 21 CFR 820 QSR
03/29/202 3 Risk management - Contents and requirements of ISO 14971
Test.
Module 2 - Product Realization
04/19/202 3 Biocompatibility and biological safety of medical devices
05/03/202 3 Clinical evaluation and clinical testing of medical devices
05/17/202 3 Design Control
06/14/202 3 Validation of processes in the medical device industry
06/28/202 3 cleaning validations within the manufacturing processes of medical devices
07/12/202 3 Marketing of medical pro
KONTAKT:
Max-Planck-Straße 17, TuttlingenBeruflichen Bildungsstätte Tuttlingen & Online
