MedicalMountains GmbH Quality manager medical technology

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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 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 who come from other industries in want to change medical technology.

Topic overview & dates

Module 1 - Quality Management
05/02/2023 Quality management for medical devices according to DIN EN ISO 13485:2016 (online)
05/16/2023 The QM representative (QMR) (online)
05/25/2023 Technical documentation according to EU-MDR - structure and content (hybrid)
06/22/2023 Quality management for medical devices according to 21 CFR 820 QSR (online)
06/27/2023 Risk management - Contents and requirements of ISO 14971 (hybrid)

Module 2 - Product Realization
07/04/202 3 Biocompatibility and biological safety of medical devices (hybrid)
07/18/202 3 Clinical evaluation and clinical testing of medical devices (hybrid)
07/26/202 3 Design Control (hybrid)
09/21/202 3 cleaning validations within the manufacturing processes of medical devices (hybrid)
09/27/202 3

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