The production sequences for medical products are comprehensively and successfully validated by the MKS validation team. Critical process steps were evaluated in risk analyses and required preventive measures and monitoring functions were implemented.
Strict compliance with all hygienic requirements and specifications is a part of all work steps. The charge production and the subsequent filling are carried out in a controlled environment, which is micro-biologically monitored at defined time intervals.
The certification of the quality management system acc. to ISO 13485 includes the documentation of processes and subsequent checks in internal and external audits and therefore constitutes the organizational framework for the production of medical devices.