PR84955

SAN DANIELE DEL FRIULI, Italy, July 30, 2020 /PRNewswire=KYODO JBN/ --

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 TUV SUD. 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 TUV SUD, specifically TUV 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 TUV SUD is valuable for LimaCorporate. Thanks to the

expertise developed by TUV SUD, 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.

About 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.

For additional information on the Company, please visit: www.limacorporate.com.

Logo - https://mma.prnewswire.com/media/997351/LimaCorporate_Logo.jpg

Limacorporate S.p.A.

Via Nazionale, 52

33038 Villanova di San Daniele del Friuli

Udine - Italy

T: +39 (0)432 945511

E: info@limacorporate.com

SOURCE: Limacorporate S.p.A.