Quality management ISO13485

A pragmatic quality management system is the basement of efficient product creation

The international requirements for quality management in the context of CE-marking are outlined in the standard EN ISO 13485 and include the specifications for compliant development, production, implementation and maintenance of medical devices within an appropriate quality management system.
We assist your company to overcome the comprehensive challenges during the entire process of suiting an adequate quality management system to your company complying with the requirements according to the international standard EN ISO 13485. The synopsis of various international standards and integration of those standards in your internal QM-system lie within the scope of our specialization as well as the development of an appropriate documentation system