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Commitment & Quality
Since its creation, Biom'Up has been committed to a quality approach that ensures high performance and safety of its products. Certified to ISO 13485 and ISO 9001 since 2006 by the SNCH, we are firmly focused on:
Complete control of all our activities,- Continuous improvement of our Quality Management System,
- Compliance with the applicable regulations (in particular, European directive 93/42/EEC).
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.
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 of the future to improve patients' Quality of Life is paramount.