Production

GRUPPO BIOIMPIANTI manages the production process from idea and design, through production, up to packaging and sterilization.

Thanks to the combination of the excellent Quality Management System, the high level of staff training, the exclusive presence of qualified suppliers, the dedicated commitment to all-round customer satisfaction and the experience acquired over the years, Gruppo Bioimpianti is now able to provide its customers with products that are among the best in the industry and which comply with the most demanding international regulations.

Our production site in Monza boasts over 4000 square meters of covered area and 3 warehouses, as well as:

  • A diverse range of machinery with over 35 CNC machines;
  • Controls for oil-free polyethylene processing: Temperature and humidity controlled production;
  • Lasers for marking metals and polymers;
  • Welding lasers;
  • Measuring machines of different types.

For the relevant processes, Gruppo Bioimpianti relies on well-established and highly qualified partners, who produce and manage their products according to the requirements of international and European reference standards (UNI EN ISO 13485 and associated/specific), making use of their expertise to obtain a final product that combines highly prestigious technical know-how.

The packaging and wrapping of medical devices is carried out in-house at Gruppo Bioimpianti by trained and competent personnel in an ISO 7 clean room annually validated according to UNI EN ISO 14644 and the requirements of standards relating to the packaging of products for clinical use (UNI EN ISO 11607, EN 868).

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