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Home Page > The Company > Commitment to Quality and Compliance

Commitment & Quality

Since its creation, Biom'up has been committed to a quality approach that ensures the high performance and safety of its products. Certified to ISO 13485 by BSI group, we are firmly focused on:

  • BSIComplete control over all our activities,
  • Continuous improvement of our processes,
  • Compliance with the applicable regulations (in particular, European directive 93/42/EEC, 21 CFR part. 820 for the USA and SOR 98/282 for Canada).

We always ensure that the necessary and relevant resources to achieve these objectives are put in place and require all employees to participate in the pursuit of these goals.

Quality To guarantee the safety of our products, we ensure the following:

  • Certified raw materials from approved suppliers,
  • A Quality Management System with complete traceability,
  • First class Quality Control laboratory,
  • Qualification of equipment , systems and process validation in accordance with CFR Sect. 820,
  • Complete virus inactivation in the manufacturing process,
  • ISO classes 7and 8 clean room facility,
  • Validated and monitored x-ray sterilisation process,

Our final goal is without compromise: The development of our biomaterials to improve patients' Quality of Life is paramount.


California Declaration of Compliance >