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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

 

requirements

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

 

Other

Coach and Trainer

Technical project lead