3D printing specialist EOS has introduced a new tool to help medical device manufacturers comply with regulatory requirements. The so-called EOS Medical Device Master File contains pre-validated process and material data and enables more efficient collaboration with approval authorities without having to disclose sensitive development data to third parties. This can significantly simplify the approval process, especially for manufacturers in regulated markets such as the USA.
The approval of new medical devices is subject to complex regulatory requirements in many countries. In the USA, extensive tests and documentation as well as a direct exchange with the Food and Drug Administration (FDA) are required. The EOS Master File provides a standardized technical basis that manufacturers can refer to when submitting new products. This avoids redundant testing processes and shortens approval times.
The master file is based on EOS’ long-established metal-based additive manufacturing process, in particular the EOS M 290 platform, which is already used in the production of implantable components such as hip cups and spinal cages.
“At EOS, we are committed to supporting our customers throughout their regulatory journey. With the EOS Medical Device Master File, we aim to help manufacturers make complex approval processes more efficient by leveraging our years of experience in supporting customers through the medical device approval process and ensuring regulatory compliance,” said Davy Orye, Head of Additive Minds EMEA at EOS.
With this initiative, EOS aims to help reduce regulatory hurdles in the field of additive manufacturing for medical applications. This gives companies the opportunity to bring innovation-driven products to market faster without losing control of their intellectual property.
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