Manufacturing of sterile products

Sterile Products

As a manufacturer of medical materials, we see it as our responsibility to combine innovation, quality and safety.

For this reason, our products are manufactured and tested in compliance with the highest quality and safety standards.

All of our production processes are validated and take place in controlled environment that meet all hygiene and cleanroom requirements.

Through our certified quality management system and comprehensive documentation, we ensure not only traceability and compliance, but also actively shape the future of safe and innovative medical products

– for reliable use in everyday clinical practice.

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To reliably, reproducibly and standards‑compliantly manufacture medical products, we at C. H. Müller combine state‑of‑the‑art technology with a deep understanding of regulatory requirements. From material selection to process validation and sterile final packaging, we rely on fully controlled workflows and documented quality. This makes us a dependable partner for manufacturers who require safe and market‑ready medical products
– flexible in execution, precise in manufacturing and consistently compliant with all applicable standards.

We offer

ISO 13485–certified certified for medical devices

MDR‑compliant development and production

Manufacturing in a controlled environment (ISO Class 8 cleanroom)

Production and packaging of sterile Class Is products

Medical device design and development, including regulatory approval support

Contract manufacturing and process services for medical devices

Validated manufacturing processes, including qualified sterilization procedure