TISSIUM received CE Mark for its first sterile biodegradable sealant in a pre-filled syringe format
TISSIUM, a privately-owned life science company developing fully synthetic, biomorphic programmable polymers, announced the receipt of a CE-mark for its sterile biodegradable sealant in a pre-filled syringe. TISSIUM also announced the completion of the transfer of its ISO 13485:2016 compliance certificate that encompasses the design, development and production of its proprietary polymer-based devices and related accessories.
The TÜV SÜD certification is for the design, development and production of TISSIUM polymers for use in vascular reconstruction in accordance with European Union Directives on medical devices. This certification from TÜV SÜD, one of the few organizations that is a designated notified body under the new European Medical Device Regulation (MDR), enables TISSIUM to leverage its proprietary research, development and manufacturing platform for multiple new products addressing novel indications going forward. TÜV SÜD’s MDR designation will also ensure the continuity of regulatory compliance and support post-MDR implementation.
“TISSIUM has been diligently working to achieve CE Marking for our products manufactured at our factory in Roncq.”, said Christophe Bancel, CEO of TISSIUM. “This milestone continues to strengthen TISSIUM’s position as the future leader in tissue reconstruction through our capacity to innovate, develop and manufacture state-of-the-art solutions for patients. We are excited to continue developing and manufacturing innovative medical devices using our proprietary platform of biomorphic programmable polymers.”
Source: Company Press Release