We consider these important Certificates and Standards with our processes
Validation and Calibration
The validation and calibration is realized in dependence on or with following Standards:
ISO 9001:2014
Quality Management SystemsISO 13485:2014
Medical devices – Quality Management SystemsDIN EN 285:2014
Sterilization, Big Steam Sterilization plantsDIN EN ISO 17665-1:2006
Sterilization of medical devices; Validation and supervision for Sterilization with humid heatDIN EN 556-1:2002-03
Sterilization of medical devices – requirements for medical devicesSPS / Software
The programming and validation of the PLC-Software and Hardware is realized appropriate GAMP («Good Automated Manufacturing Practice Supplier Guide for Validation of Automated Systems in Pharmaceutical Manufacture»).Logging
The logging of protocols and saving of all datas, recipes, keywords and authorization is done appropriate FDA requirements (optional).