Home Technical Emphasis Qualifications Cooperation Profile Download Contact Impressum  



Technical Emphasis





Management of development processes


Implementation of process models for the software development


and due consideration of regulatory provisions


Implementation of agile concepts, especially in medical



device industries

Integration of agile concepts and regulatory provisions


Support for the organization of standard operation procedures


Scrum Coach and Scrum Master





Usability, Requirement Management and System Analysis

Elicitation and documentation of user needs and system



Elicitation and documentation of usability requirements

Document -, design- and code reviews

Model based system analysis using SysML

Functional and technical analysis and design


Quality management, Verification and Validation


Validation of processes and products


Internal audits und supplier audits


Gap analysis for documentation and processes


Risk management (EN ISO 14971)


Structure and Content of the Technical File


Corrective and preventive actions (CAPA)


Configuration-, problem- and change management


Test management



Coach and Trainer

Technical project lead