TÜV certification

ISO 13485 successfully obtained

ISO 13485 certification confirms our quality standards

An important milestone for KBM: KBM Kollagen und Biomaterialien für Medizinprodukte GmbH has been successfully certified according to ISO 13485:2016.
The certification, awarded by TÜV SÜD Product Service GmbH, confirms that our processes in design, development, production, and distribution meet the highest international quality and safety requirements for medical devices.
For our customers, this means:
• Reliable, reproducible quality
• Regulatory certainty
• Stable and transparent processes along the entire value chain
The certified scope covers the provision of animal raw materials (collagen, elastin) and plant-based raw materials for use in medical devices.
With ISO 13485 certification, we are underlining our long-term commitment to quality, compliance, and partnership-based cooperation in the regulated medical device environment - both today and in the future.

We would like to express our special thanks to all the employees involved, whose commitment and expertise have contributed significantly to this success - we are delighted about this important milestone.

Certificate details:
• Standard: ISO 13485:2016
• Certification body: TÜV SÜD Product Service GmbH
• Validity: January 12, 2026 – January 11, 2029

Download the TÜV certificate as a PDF here.

Your KBM Team