Product category: Other equipment and devices for physiotherapy and orthopaedy
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 is also audited in accordance with the requirements of Annex II of the Directive 93/42/EEC on medical devices.
Since 2003, Regen Lab SA has been committed to the development of a unique expertise for the design and manufacturing of high-quality medical devices, intended for cells therapies and for the preparation of autologous platelet-rich plasma (PRP) from the patients own blood, to be used in bedside procedures.
Regen Lab SA manufactures several CE-marked products to fit to medical disciplines where PRP represents a treatment option. Patients can expect very good outcomes for the treatment of their chronic and surgical wounds, dry eye syndrome and other ophthalmic conditions, sport-related wounds and even alopecia, as demonstrated through the clinical studies Regen Lab has set-up over the past few years.
In the last five years, over 2 million patients have been treated using Regen Lab products and another 10 thousand have benefited from bone marrow stem cell kits. The company invested in a new Good Manufacturing Practice (GMP) facility located at the Mont-sur-Lausanne (canton of Vaud) beginning production in 2017. It is planned that this new peak performance industrial platform will allow the treatment of over 1 million patients per year.