MedicalMountains GmbH

Service Provider

MedicalMountains GmbH Quality manager medical technology module 1

content

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.

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.

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.

exam and graduation
After each module, the technical knowledge and skills acquired are tested in writing. Please register for the exam via our appointment calendar . After successfully completing all 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 after passing all three module examinations. If you book all three modules at once, you will receive a special price of EUR 8,890.00 .

You can use the following links to book additional modules or the entire certificate course:

Quality manager medical technology module 2

Quality manager medical technology module 3

Overall quality manager for medical technology