Country for PR: United Kingdom
Contributor: PR Newswire Europe
Thursday, July 30 2020 - 22:00
LimaCorporate Is The First Italian Company To Obtain The EU Quality Certificate Under The MDR
SAN DANIELE DEL FRIULI, Italy, July 30, 2020 /PRNewswire-AsiaNet/ --

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:

Logo -

Limacorporate S.p.A.
Via Nazionale, 52 
33038 Villanova di San Daniele del Friuli 
Udine - Italy 
T: +39 (0)432 945511 

SOURCE: Limacorporate S.p.A.