Pointing out the international requirements of EU MDR 2017/745, ISO 13485, MDSAP but also ISO 27001 and other regulations and how these can be efficiently combined in an integrated management system and efficiently used and applied by the employees.

We support and coach you in the understanding and implementation of all requirements of SaMD and MDSW.

Wir unterstützen Sie in der Umsetzung des Medical Device Single Audit Program (Australia, Brazil, Canada, Japan, USA).

EN ISO 19011 – Implementation of internal and supplier audits

Information security management systems ISO 27001.

In this coaching you will learn how to implement ISO 27001 in your company.

Target groups

Companies, executives, IT employees, ISMS officers, data protection officers

The responsible person according to EU MDR 2017/745 §15. We coach and support you in the requirements of this new role. 

GDPR – Implementation of the current data protection guidelines in your company

Smart business processes in international medical technology companies

Demonstration of the international requirements of MDR, ISO 13485, MDSAP and further global regulations and how these can be efficiently summarized in an integrated management system and efficiently used and applied by employees.

The EU representative for third countries – manufacturer – role – tasks – obligations

Preparation of clinical evaluations according to EU MDR 2017/745.