Lithoz announced a critical regulatory certification that will almost certainly grow their business.
The certification in question is ISO 13485 for their quality management system. This ISO standard is for the production of medical devices and is one of the critical standards to meet before further regulatory approvals are achieved.
Lithoz is a manufacturer of advanced industrial 3D printers that produce highly detailed ceramic parts, based in Vienna. They produce multiple ceramic 3D printer models, along with a wide range of ceramic materials for them.
Lithoz explains the new certification’s importance:
“Securing the ISO 13485 certification— internationally recognised as the gold standard for quality management in medical device manufacturing— marks Lithoz’s next organizational milestone, underlining their focused commitment to meeting the stringent requirements of patient safety, precision, and regulatory compliance. This achievement builds on Lithoz‘s existing ISO 9001 certification and enables FDA QSR compliance. That puts the company straight onto the starting blocks to serve the industry‘s growing demand for reliable, production-ready medical and dental applications.”
This is what it is about: the ability to produce medical devices. Ceramic material is rigid and, most importantly, chemically resistant and often biocompatible. A possible application would be human implants, for example.
However, that cannot be done without the required regulatory approvals. In other words, medical device providers seeking ceramic equipment would automatically stroke Lithoz off their list if they did not have the required certifications. By adding this certification, Lithoz is positioning for further certifications that will “unstroke” those potential deals.
The result could be a significant increase in sales of 3D printers to a new set of customers for the company.
Via Lithoz
