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Minitube achieves ISO 13485 certification

Strengthening quality leadership in reproductive technologies.

3 September 2025
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logoMinitüb GmbH (Minitube) has successfully passed a three-day audit conducted by TÜV Süd and is now officially certified according to ISO 13485, the globally recognized standard for quality management systems in the development and production of medical devices.

Quality management has always been a cornerstone of Minitube's philosophy. The company has long been certified under ISO 9001:2015, consistently aligning its processes with transparency, safety, and continuous improvement. Achieving ISO 13485 certification now further confirms Minitube’s compliance with the most stringent international requirements for safety, risk management, and traceability in the field of medical devices.

During the audit, the TÜV Süd assessors emphasized the systematic structure of Minitube's quality management system, the performance of its digital solutions, and the strong commitment of its entire team. This feedback underscores that quality is not merely documented at Minitube but actively embraced throughout the organization.

With ISO 13485 certification, Minitube strengthens its role as a trusted global partner for safe and innovative products. Headquartered in Tiefenbach, Germany, Minitube is recognized as a leading specialist in technologies for assisted reproduction in animals as well as in human reproductive medicine.

September 2, 2025 - Minitube

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