From the very beginning, Minitube has always strived to stand out through highest quality. This was formalized by an ISO 9001 certification as early as 2004. The quality management system in practice has been checked and improved year after year since then.

Among others, our quality processes include regular consultations with customers, an effective feedback and complaint handling system, an employee suggestion system, internal and external audits.

All proprietary products are double checked by in-line process monitoring at the production site and by our QM department in Germany. An in-house quality lab verifies the specifications and tolerances of approx. 3,000 samples per year. Some products are even tested piece by piece instead of drawing samples. All Minitube consumables for reproductive medicine getting in contact with gametes or embryos are strictly validated. Every batch is tested for bioburden before being sterilized and needs to pass a mouse embryo assay (MEA) and an endotoxicity test (LAL).

Currently, Minitube is in the process of introducing a quality management system according to ISO 13485:2016 and getting compliant with the standards of the new Medical Device Regulation (MDR).

Our commitment to consistent quality is a benefit to you - enabling optimum treatment results and low failure rates.