Medical device company, LimaCorporate, obtained the EU Quality Management System (QMS) certificate under the new European Medical Devices Regulation (MDR) from TÜV SÜD.
The organisation received this certification in accordance with the new MDR regulation for its line of customised products - prostheses made for the specific needs and requirements of patients, which formalised development in 2015.
As a result of receiving this certification, LimaCorporate is now allowed to place custom-made implantable devices in the market in compliance with MDR requirements, one year ahead of the date of application - which will go into effect in May 2021.
Luigi Ferrari, CEO of LimaCorporate, commented on the news: "In the context of bringing profound changes to the medical device industry, the partnership with TÜV SÜD is valuable for LimaCorporate.
“Thanks to the expertise developed by TÜV SÜD, especially for the MDR, LimaCorporate has foreseen and evolved its processes so that the devices comply with the relevant requirements of the new regulation, which is a milestone for LimaCorporate and Italian medical device manufacturers.
“This agility and technical preparation in LimaCorporate has allowed us to anticipate the future of technology and transform orthopaedics once again.”