10MD has been granted a quality management certificate and is now ready for market introduction in Europe.
In order for personal protection equipment (PPE) to be legally placed on the European market it must bear the CE mark. The PPE Regulation (EU) 2016/425 (which replaced the previous Directive 89/686/EEC) is the basis upon which PPE manufacturers are authorised to affix the CE mark to their products. The Regulation provides for three categories: Simple (Category I), Intermediate (Category II) and Complex (Category III). 10MD products are within Category III, which requires control by a Notified Body on the manufacturer's production and quality system.
The Notified Body SGS Ltd has reviewed and approved the 10MD quality system. SGS concluded that 10MD management and manufacturing processes conforms with applicable statutory, regulatory and effectiveness requirements.
"Our team has worked hard to put the quality system in place. The certification is an acknowledgment that 10MD fulfills the high requirements on PPE category III manufacturers," says Fredrik Gellerstedt, CEO at 10MD.
10MD has developed the first radiation protection textile - TeXray. TeXray is patented and constitutes of a breathable textile that protects the user from harmful radiation during diagnostic and surgical interventions. HeadPeace is the company's first product and was developed to minimize cranial exposure to ionizing radiation. HeadPeace was recently clinically validated by healthcare professionals in Ireland and Sweden.
* HeadPeace and TeXray are trademarks of Ten Medical Design AB.