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.