SAN DANIELE DEL FRIULI, Italy, July 30, 2020 /PRNewswire/ -- LimaCorporate announces that it is the first Italian company to obtain the EU Quality Management System certificate under the new European Medical Devices Regulation (MDR) from TÜV SÜD. In 2015, LimaCorporate formalized the development of a line of customized products - prostheses made for the specific needs and requirements of patients. It is precisely for these custom products that LimaCorporate has received this certification in accordance with the new MDR regulation.
With this certification, LimaCorporate is allowed to place custom-made implantable devices in the market in compliance with MDR requirements, one year ahead of the date of application; this will go into effect in May 2021. The certification process was brilliantly passed thanks to consolidated regulatory experience, competence and commitment in the search for new materials and technologies, such as pioneering the use of 3D printing in the production of prosthetic implants, and constant attention to areas of improvement.
LimaCorporate has always been committed to attaining the highest levels of quality. In 2006, when the company started designing patient-specific medical devices and utilizing a new manufacturing technology, i.e., 3D printing, there was no roadmap for the creation of quality systems. Over the years, LimaCorporate has evolved, improved, and validated its quality approach to always be ahead of the curve. LimaCorporate officially launched ProMade, a service that provides custom-made solutions, in 2015.
Considering the high variability associated with these complex orthopedic reconstructions, this certification is a confirmation of all the hard work and dedication to quality that began back in 2006. This achievement is also a result of the company's collaboration with TÜV SÜD, specifically TÜV Italia, the certification body that adds value to its partners and customers through a comprehensive portfolio of testing, certifying, and auditing.
"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 orthopedics once again," explains Luigi Ferrari, CEO of LimaCorporate.
LimaCorporate is a global medical device company providing reconstructive and custom-made Orthopedic solutions to surgeons who face the challenges of improving the quality of life of their patients. Based in Italy, LimaCorporate is committed to the development of innovative products and procedures to enable surgeons to select ideal solution for every individual patient. LimaCorporate's product range includes large joint revision and primary implants and complete extremities solutions including fixation.