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 is also audited in accordance with the requirements of Annex II of the Directive 93/42/EEC on medical devices.
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