Quality
From the very beginning, Minitube has aimed for the highest quality. This commitment was formalized with ISO 9001 certification in 2004 and has been continuously refined ever since.
Our quality processes include regular customer consultations, effective feedback and complaint handling, employee suggestions, and internal and external audits. Proprietary products are double-checked through in-line process monitoring and by our QM department in Germany. An in-house QA lab inspects around 3,000 samples per year, and some products are tested individually. All consumables for reproductive medicine that are in contact with gametes or embryos are strictly validated, passing the mouse embryo assay (MEA) and endotoxicity test (LAL).
Since September 2025, Minitube has been officially recognized as a medical device manufacturer under ISO 13485. This certification ensures our products meet the highest standards of safety, reliability, and regulatory compliance. It confirms that we:
In an ongoing process, we are aligning our product registrations with the European Medical Device Regulation (MDR) to stay at the forefront of regulatory compliance.
Our quality processes include regular customer consultations, effective feedback and complaint handling, employee suggestions, and internal and external audits. Proprietary products are double-checked through in-line process monitoring and by our QM department in Germany. An in-house QA lab inspects around 3,000 samples per year, and some products are tested individually. All consumables for reproductive medicine that are in contact with gametes or embryos are strictly validated, passing the mouse embryo assay (MEA) and endotoxicity test (LAL).
Since September 2025, Minitube has been officially recognized as a medical device manufacturer under ISO 13485. This certification ensures our products meet the highest standards of safety, reliability, and regulatory compliance. It confirms that we:
- Develop and manufacture medical devices to the highest quality standards
- Maintain comprehensive risk management and traceability
- Operate structured, documented, and continuously optimized processes
- Focus on patient safety throughout the whole product life cycle
In an ongoing process, we are aligning our product registrations with the European Medical Device Regulation (MDR) to stay at the forefront of regulatory compliance.
