About Us
Certifications
Committed to the highest industry standards for sterilization and healthcare compliance.
ISO 13485 Certification
Imtech-Steri AG is ISO 13485 certified, demonstrating our commitment to quality management systems for the design, development, production, and servicing of medical devices and related services.
European Standards Compliance
In addition to our ISO 13485 certificate, we voluntarily comply with key European standards:
SN EN 285
Requirements and testing for large steam sterilizers in healthcare.
SN EN ISO 17665-1
Standards for the sterilization of healthcare products using moist heat.
At Imtech-Steri, we continuously strive for excellence, ensuring our solutions meet the strictest international regulations for quality and safety.
PLC & Software Validation
We ensure reliability and compliance in automation and control systems. Our PLC and software programming is fully compliant with GAMP guidelines:
GAMP (Good Automated Manufacturing Practice)
Supplier Guide for Validation of Automated Systems in Pharmaceutical Manufacturing.
At Imtech-Steri, we adhere to the highest standards in automation and software validation, ensuring seamless integration and compliance for pharmaceutical and industrial applications.