Quality Management
The expectations of our clients can only be met by adapting the management concept to meet all specifications. This guarantees all-encompassing quality efficient internal processes while, at the same time, ensuring all aspects relating to environmental protection, plant safety and occupational health and safety.
The needs of our clients enjoy the highest priority
At RESORBA we always strive to fulfil the wishes and demands of our clients and partners as fully as possible. Open communication with the users of our products, with external partners, and our own employees provides an important foundation for collaboration. The quality management system was developed and organised in cooperation with all the people and departments involved, specifically optimised, and set down for all employees.
The quality management system guarantees our clients and partners that RESORBA observes and complies with all the requirements and applicable laws and regulations. These also include standard DIN EN ISO 13485:2003.
Further underlying regulations are:
- Council Directive 93/42/EEC concerning medical devices,
- German Medical Devices Act (MPG),
- German Medical Devices Safety Planning Guidelines (MPSichV),
- further regulations issued within the framework of the MPG
- harmonised standards
- monographs of the European Pharmacopoeia (Pharm. Eur.)
- and - where appropriate - the German Medicines Act (AMG)
Visible expression of our convictions
The quality of our products and our dedicated involvement for the benefit of the environment and safety are a sign of our responsibility and our accountability.