Certificates, Regulations and Standards

We consider these important certificates, regulations and standards with our processes

Validation and Calibration

The validation and calibration is realized in dependence on or with following regulations and standards:

ISO 13485

Medical devices – Quality Management Systems
Management System in preparation - Certification planned for Q1 2025

SN EN 285

Sterilization, Big Steam Sterilization plants

SN EN ISO 17665-1

Sterilization of medical devices; Validation and supervision for Sterilization with humid heat

Regulation (EU) 2017/745 (MDR)

Medical Devices Ordinance (MedDO)

Federal Act on Medicinal products and Medical Devices (Therapeutic Products Act, TPA)

SN EN 556

Sterilization of medical devices – requirements for medical devices

SPS / 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).