LimaCorporate Becomes First Italian Company to Obtain EU Quality Certificate Under MDR for Custom Orthopedic Implants

SAN DANIELE DEL FRIULI, Italy, July 30, 2020 /PRNewswire/ -- LimaCorporate announced that it has become the first Italian company to obtain a European Union Quality Management System certificate from TÜV SÜD in accordance with the new European Medical Device Regulation (MDR). In 2015, LimaCorporate formally initiated the development of a range of customized products, primarily prostheses designed to meet the specific needs and requirements of individual patients. Specifically, it is these customized products from LimaCorporate that have secured this certification under the new MDR framework.

With this certification, LimaCorporate is now authorized to place custom-made implantable devices on the market one year earlier than the application date, in accordance with the Medical Device Regulation (MDR) requirements, as the new MDR came into effect in May 2021. The certification process proceeded very smoothly, attributable to the enhanced regulatory expertise and robust capabilities following the merger, the commitment to sourcing new materials and technologies—such as the pioneering use of 3D printing in the production of prosthetic implants—and the continuous focus on areas for improvement.

LimaCorporate has always been committed to achieving the highest level of quality. In 2006, when the company began designing medical devices for specific patients and utilizing new manufacturing technologies (3D printing), there was no "roadmap" for establishing a quality system. Over the years, LimaCorporate has continuously developed, improved, and validated its quality approach in order to maintain its leading position. In 2015, LimaCorporate officially launched ProMade, a service that provides customized solutions.

Given the high variability associated with these complex orthopedic reconstructions, this certification acknowledges Lima Corporate’s dedicated efforts and commitment to quality since 2006. Achieving this milestone is also a testament to the collaboration between Lima Corporate and TÜV SÜD—particularly TÜV Italia—which creates value for partners and customers through an integrated approach of testing, certification, and auditing.

Lima Corporate CEO Luigi Ferrari (Luigi Ferrari) explained: “Against the backdrop of profound changes reshaping the medical device industry, partnering with TÜV SÜD has been highly valuable for LimaCorporate. Leveraging TÜV SÜD’s expertise specifically developed for the Medical Device Regulation (MDR), LimaCorporate has proactively anticipated and enhanced its processes, ensuring that our devices comply with the relevant requirements of the new regulations. This achievement marks a significant milestone for both LimaCorporate and Italian medical device manufacturers. LimaCorporate’s agility and technical readiness enable us to engage in future technological advancements and once again drive transformation in orthopedics.”