Minitüb GmbH successfully achieves ISO 13485 certification
A major milestone for Minitube Human ART: After an intensive three-day audit by two TÜV Süd auditors, our quality management system was successfully certified. Minitube Human ART is now officially recognized as a medical device manufacturer in accordance with ISO 13485.
The ISO 13485 certification confirms that Minitube Human ART:
The auditors from TÜV Süd were particularly impressed by the well-thought-out structure of our quality management system, the performance of the QM software and the great commitment of the entire Minitube Human ART team. This feedback clearly shows that quality at Minitube Human ART is not only documented but also actively practiced.
What does this mean for our customers?
Shortly stated: maximum safety, reliability and quality.The ISO 13485 certification confirms that Minitube Human ART:
- Develops and manufactures medical devices to the highest quality and safety standards
- Resolutely fulfills all legal and regulatory requirements
- Commands a comprehensive risk management system and seamless traceability
- Works with clearly structured and documented processes that are regularly monitored and optimized
- Consistently focuses on product safety and patient protection - from conception to finished product
An audit that impressed
The auditors from TÜV Süd were particularly impressed by the well-thought-out structure of our quality management system, the performance of the QM software and the great commitment of the entire Minitube Human ART team. This feedback clearly shows that quality at Minitube Human ART is not only documented but also actively practiced.Quality as a lived promise
Our ISO 13485 certification confirms our commitment to providing our customers not only with innovative solutions, but also with safe and reliable ones. For Minitube Human ART, quality is not just an empty promise – it is an integral part of our daily work.