Bomi Group > Services > Labelling & kitting

Since its inception the biomedical and IVD sector has been a market with a marked tendency towards globalization. Indeed, whilst the need for health is universally recognized as a primary good, and whilst the sector is characterized by a constant and high level of technological innovation, these factors mean that a business can only be successful if it targets a global market.

This in turn obliges business to adhere to local regulations which often are different from their own, both in terms of the requirements which must be fulfilled in order to be able to place the device on a particular national market, and in terms of the information which must be provided to the user. These aspects of trading on a global market render it necessary to modify the product “on-site”, making a variety of changes:

Labelling

  • Labelling of the product with information on technical characteristics, destination, origin and handling
  • Re-labelling of the product in order to make it available on the market in the local language.
  • Inclusion of additional information
  • Alignment of the barcodes with international standards

Kitting

  • Assembly of specific kits in order to meet commercial or regulatory requirements;
  • Creation of new products using parts which could be sold separately;
  • Classification of kitting activities according to product type;
  • Use of premises suitable for the management of perishable and sensitive material;
  • Clustering of products according to the market and end user.

Bomi is able to meet all these requirements with certified activities which allow the qualitative properties of the device to remain unaltered and makes it possible to guarantee the total traceability of the product.

It is with great pride that we were successful in obtaining ISO 13485 certification dealing in particular with medical equipment.