EOS launches Medical Device Master File solution to expedite regulatory approval for medical device makers; system allows manufacturers to submit proprietary data directly to regulators

EOS, a global leader in additive manufacturing (AM) technologies, services and materials, today announced its latest advancement in regulatory compliance support for medical device manufacturers. The EOS Medical Device Master File provides prevalidated technical data, helping streamline the regulatory approval processes while protecting proprietary information.

Regulatory compliance in the United States requires extensive testing, documentation, and engagement with governing agencies, which can lead to significant delays. The EOS Master File allows manufacturers to submit Intellectual Property (IP) directly to medical regulators, ensuring compliance while protecting proprietary data from disclosure to customers. Additionally, the Master File serves as a reference point for multiple device manufacturers, reducing redundant regulatory steps and expediting time to market.

With more than two decades of legacy of innovation and experience in the medical device manufacturing sector, EOS has cemented its reputation as a trusted partner in the AM medical industry. The EOS M 290 metal AM platform is well regarded for its production of approved medical devices, including hip cups, tibial trays and spinal cages.