Notified body grants 10MD with a quality certificate

Apr 24, 2018

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 Directive - formally known as  89/686/EEC - is the basis upon which PPE manufacturers are authorised to affix the CE mark to their products. The Directive 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 fulfils the high requirements on PPE category III manufacturers ", says Fredrik Gellerstedt, CEO at 10MD.

10MD has developed the first radiation protection textile - SafeTex. SafeTex is patented and constitutes of a breathable woven fabric 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 of ionizing radiation. HeadPeace was recently clinically validated by healthcare professionals in Ireland and Sweden.    

 

For further information, please contact Petra Apell, founding partner, +46 705 735262, petra.apell@10md.se

 

* SafeTex is a trademark of Ten Medical Design AB.