Quality product & management

REGEN LAB’s ambition is to become a international leader in regenerative medicine based on autologous medical/surgical treatments and to provide medical medical devices of the highest quality and safety for the patient and the user. This is a commitment to public health and patient welfare.

Thus, Regen Lab has set up a typical production centre with the installation of new infrastructure with innovative and efficient technologies, in order to ensure the production of the production of reliable and high value-added devices while respecting the well-being of well being of our employees.

Regen Lab Quality System Management ensures the consistency of our products quality in total GMP compliance. Our production facility rooms atmosphere is monitored to satisfy non-pyrogenic medical devices manufacturing.

Regen Lab follows a stringent approach to regulatory matters and Quality System Management. We operate within the framework of the ISO 13485 Norms, which combines the requirements medical device manufacturers must incorporate into their management systems. Our quality system also complies with the requirements of the European Regulation 2017/745 on medical devices.