Successful external audit of 10MD manufacturing processes

The Notified Body SGS Ltd recommends Ten Medical Design (10MD) for certification of the manufacturing processes according to the new PPE Regulation (EU) 2016/425, Module D.

“The positive result from the surveillance audit performed by SGS is a team effort by 10MD and our subcontractors,” says Fredrik Gellerstedt, CEO at 10MD.

10MD has developed the first radiation protection textile - NAFT. NAFT(Texray) is patented and constitutes of a breathable textile that protects the user from harmful radiation during surgical interventions. HeadPeace is the company´s first product and is produced according to the certified manufacturing process. HeadPeace is an efficient protective headwear for surgeons and hospital staff, which is designed for personal safety.