LimaCorporate, S.p.A., based in San Daniele del Friuli, Italy, is the first Italian company to obtain the European Union (EU) Quality Management System certificate under the new European Medical Devices Regulation from TÜV SÜD. This certification covers a line of customized products the company formalized in 2015.
LimaCorporate: First Italian Company With EU Quality Certificate
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Beating Their Deadline
At this point, LimaCorporate is permitted to put custom-made implantable devices on the market in compliance with Medical Devices Regulation requirements, well ahead of the date of application (goes into effect in May 2021). The company credits consolidated regulatory experience, as well as 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.
CEO Luigi Ferrari told OTW, “We have worked hard on updating our Standard Operating Procedures (SOPs) to ensure they match the new Medical Devices Regulation requirements. Indeed, they have been positively evaluated by TÜV SÜD, the certification body that offers a comprehensive portfolio of testing, certifying, and auditing. In addition, SOPs for the evaluation of clinical evidence regarding custom-made devices have been developed and appreciated by TÜV SÜD.”
Constantly Evolving Processes
“In the context of bringing profound changes to the medical device industry, the partnership with TÜV SÜD is valuable for LimaCorporate,” explained Ferrari. “Thanks to the expertise developed by TÜV SÜD, especially for the Medical Devices Regulation, 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 have allowed us to anticipate the future of technology and transform orthopedics once again.”
“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,” said the corporate news release. “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.”
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Discussion
This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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