The company Congenius AG is a consulting firm specializing in the areas of medical technology (MedTech), healthcare (eHealth), and life sciences. The company's core activities include:
* Consulting and support in the development and implementation of quality management systems (QMS)
* Regulatory Affairs and technical documentation
* Process optimization and engineering
* Product development and safety
* Clinical trials and research
* Support in complying with regulatory requirements and standards (e.g. 21 CFR 820, MDR, ISO 13485)
The company offers its services to companies in the medical technology, pharmaceutical, and healthcare industries, supporting them in addressing challenges in the areas of quality, regulatory affairs, and product development.