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.”
About TÜV SÜD
TÜV SÜD is a premium quality, safety, and sustainability solutions provider that specializes in testing, inspection, auditing, certification, training, and knowledge services. Since 1866, the company has remained committed to its founding principle of protecting people, property and the environment from technology-related risks. Headquartered in Munich, Germany, TÜV SÜD is represented in more than 1,000 locations worldwide. TÜV SÜD operates globally with a team of more than 24,000 multidisciplinary experts recognised as specialists in their respective fields. By combining impartial expertise with invaluable insights, the company adds tangible value to businesses, consumers and the environment. The aim of TÜV SÜD is to support customers with a comprehensive suite of services worldwide to increase efficiency, reduce costs and manage risk. Visit www.tuvsud.com
