LimaCorporate is the first Italian company to obtain the he EU Quality Management System Certificate under Medical Devices Regulation (MDR) for Class III Custom-Made devices03/06/2020
LimaCorporate is very proud to announce that the company has obtained the EU Quality Management System Certificate under Medical Devices Regulation (MDR) for Class III Custom-Made devices and is, therefore, the first medical device company in Italy and among the first in Europe to complete the process, one year ahead of the new May 26, 2021 deadline.
LimaCorporate has always been committed to attaining the highest levels of quality for the ProMade design service and the associated custom-made devices. The certificate allows LimaCorporate to place on the market class III (implantable devices) custom-made products under MDR. This means that each custom-made device is compliant with a strict set of requirements from the design process, to regulatory documents, including specific labeling and Instructions for Use, as well as the activities related to Periodic Safety Update Report (PSUR), Post Market Clinical Follow Up (PMCF) and Implant Card.
The certification is confirmation of the hard work, dedication, and focus on quality that goes hand-in-hand with a pioneering approach in applying different manufacturing technology as LimaCorporate has done with 3D printing, which started with the first implant over 13 years ago.
A big thank you hence goes to the Pro##Made##, Regulatory, Clinical and Quality Departments that have worked tirelessly to assure LimaCorporate this important certificate.
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