Certificate courses

Target Audience
The MedicalMountains certificate course is aimed at employees in quality management who are responsible for implementing the specific requirements in the development, manufacture and monitoring of medical devices and want to update their specialist knowledge, as well as at managing directors or QM specialists who want to switch from other industries to medical technology.

Contents
The course consists of three modules. In module 1 you will learn all the important basics of quality management in medical technology. Module 2 (product realization) imparts QM knowledge in relation to the development of medical devices. Module 3 (Control) deals with important QM topics concerning the monitoring of the manufacturing process of medical devices. A total of 18 full-day seminars will be attended, spread over the period from 22.01.2019 to 13.11.2019.

Further information: PDF.

Target Audience
The MedicalMountains certificate course is aimed at employees from the areas of regulatory affairs and quality management, those responsible for first-time marketing, development managers, employees who are responsible for compliance with national and international legal regulations, and managing directors.

Contents
As Regulatory Affairs Manager, there is close cooperation with the relevant regulatory institutions and testing bodies with regard to national and EU standards and regulations. In addition, regulatory documents are compiled and applied and risk and quality management are intensively supported. In order to support you with this comprehensive topic, MedicalMountains offers a complete course tailored to the practice. The course consists of two modules. A total of ten full-day seminars are attended, spread over the period from 14.05.2019 to 23.10.2019.

Further information: PDF.

Target Audience
The MedicalMountains certificate course is aimed at employees in quality management and development & design who are responsible for product realisation and the associated specific requirements in the development and manufacture of medical products and who wish to update their specialist knowledge, at managing directors and QM specialists who wish to switch from other industries to medical technology.

Contents
The course consists of two modules. In module 1 you will learn all the important basics of quality management in medical technology. Module 2 (product realization) imparts QM knowledge in relation to the development of medical devices. A total of 11 full-day seminars are attended, spread over the period from 22.01.2019 to 09.07.2019.

Further information: PDF.

Target Audience
The MedicalMountains certificate course is aimed at employees in quality management who are responsible for the specific requirements in the manufacture of medical devices, in particular for monitoring and control, and who want to update their specialist knowledge, at managing directors and QM specialists who want to switch from other industries to medical technology.

Contents
The course consists of two modules. In module 1 you will learn all the important basics of quality management in medical technology. Module 3 (Control) deals with important topics concerning the monitoring of the manufacturing process of medical devices. A total of 11 full-day seminars are attended, spread over the period from 22.01.2019 to 13.11.2019.

Further information: PDF.

Target Audience
The MedicalMountains certificate course is aimed at employees and newcomers with an assistant function who provide administrative support to the head of quality management in medical technology or to the management in the implementation and support of the management system.

Employees who already have a long track record in quality management and/or are aiming for a leading position in quality management are recommended to attend the courses Quality Manager Medical Technology or Quality Specialist Medical Technology with a focus on development or production.

Contents
The course imparts a practice-oriented basic knowledge of quality management in medical technology as well as competence in various instruments of quality management. A total of 7 full-day seminars and 1 half-day seminar will be attended, spread over the period from 30.04.2019 to 05.12.2019.

Further information: PDF.

Target Audience
The MedicalMountains certificate course is aimed at semi-skilled workers and administrators in the medical device industry who are involved in product creation and product and process testing under quality aspects and thus actively participate in quality assurance and quality improvement.

Contents
The course imparts practice-oriented knowledge of quality assurance in medical technology in order to monitor and improve the quality of products and processes in your area of responsibility. A total of 5 full-day seminars will be attended, spread over the period from 19.03.2019 to 04.04.2019.

Further information: PDF.

Target Audience
The MedicalMountains certificate course is aimed at employees who are allowed to fill in the position of the responsible person in accordance with the requirements of Art. 15 of the European Medical Devices Regulation 2017/745 (EU-MDR).

Content
The course provides practice-oriented knowledge on the tasks and duties of the person responsible according to Art. 15 EU-MDR, on quality management, technical documentation, clinical evaluation/clinical testing and post-market observation. A total of 6 full-day seminars will be attended over the period from 30.01.2019 to 23.07.2019.

Further information: PDF.