Quality Management at Greggersen
Responsibility we live by.
More than just a standard
Quality is the foundation for safety, trust and the reliability of our products & systems.
Particularly in sensitive areas such as medical technology and central gas supply systems, we bear a special responsibility, as patient safety ultimately depends on our work. This is why we have established a quality management system that goes far beyond regulatory requirements.
As a manufacturer of medical devices, we operate a quality management system according to ISO 13485:2016 (EN ISO 13485:2016/AC:2018, EN ISO 13485:2016/A11:2021) and meet the requirements of Annex IX, Chapter I of Regulation (EU) 2017/745 (MDR). This system is continuously developed and adapted to new legal regulations to ensure maximum safety and compliance at all times.Â
Furthermore, we work according to a structured quality management system certified to DIN EN ISO 9001:2015. This standard provides a globally recognised framework for clear, efficient processes, continuous improvement and a consistent focus on customer satisfaction.
Certified. Practiced. Evolved.
As a manufacturer of medical devices, Greggersen Gasetechnik GmbH maintains a comprehensive, certified quality management system.
Our quality management system covers all business areas from design and development through manufacturing, final inspection and sales to maintenance and repair. This ensures that quality is reliably implemented and demonstrably lived at every single step.
To meet this commitment in the long term, our quality management is continuously reviewed, maintained and further developed. This allows us to adapt to new legal, regulatory and safety requirements at any time and to optimise our processes sustainably.
Quality means to us
- clear, documented processes ensuring transparency
- continuous improvement of all operations
- precise traceability and clean documentation
- regular internal and external audits
- Training & qualification of all employees
- Supplier quality meeting our high standards
- Risk management to identify and eliminate hazards
Transparency is a matter of course for us.
All current certificates are available for download on this page.