We are delighted to announce that Neotherix has achieved the milestone of ISO 13485 certification - the standard specifying comprehensive requirements for quality management systems used by medical device manufacturers and distributors.
We are certified to both ISO 13485:2003 and EN ISO 13485:2012 for the "design and manufacture of sterile bioresorbable wound repair products." The award of this certification (by the Notified Body SGS) demonstrates Neotherix' commitment to high standards of quality. SGS is accredited by UKAS to assess whether manufacturers and their medical devices meet the requirements set out in European legislation.
Commenting on the accomplishment, CEO Prof. Mike Raxworthy said "Neotherix Ltd is committed to the highest level of quality in all our operations, including the development, manufacture, sale and support of our products and services. Our overall objective is to provide high quality medical technology and regenerative medicine products and services that satisfy customer needs. Attaining the high standards demanded by ISO 13485 certification is a very significant milestone in our path towards eventually gaining a CE marking for our lead product EktoTherix™, and I'm very proud of this achievement."
Independent verification of our certification status can be found online through SGS's Certified Client Directory .