LIME has established a quality management system according to DIN EN ISO 13485:2016 and has been certified by DQS Med. ISO 13485 certification guarantees patient safety and facilitates access to the international market for our AnyHand product.
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As an internationally recognised standard, DIN EN ISO 13485 defines the official requirements for a comprehensive quality management system of medical device manufacturers. The certification places high demands on exact compliance with all process steps. Special attention is paid to consistent and complete documentation and risk management.
Thanks to the implementation of the quality management system according to this standard, we demonstrate our ability to manufacture safe and effective medical devices that meet both the legal requirements and the expectations of our customers.
We would like to thank the Nemius Group , our strong partner, who made the certification possible without any major or minor deviation.
