EOS has introduced its Medical Device Master File to provide pre-validated technical data and streamline regulatory approval processes wile protecting proprietary information.
Regulatory compliance in the United States requires extensive testing, documentation, and engagement with governing agencies, an often time-consuming process. The EOS Master File has therefore been developed to enable manufacturers to submit Intellectual Property (IP) directly to medical regulators, ensuring compliance while protecting proprietary data from disclosure to customers. Additionally, EOS says, the Master File serves as a reference point for multiple device manufacturers, reducing redundant regulatory steps and expediting time to market.
Designed to expedite regulatory approval by offering a single, validated source of technical data, the EOS Master File promises to reduce repetitive testing, lower regulatory friction and minimise delays in market entry. Critical parameters will have been assessed and approved, redundant verification processes avoided, and testing reduced, according to EOS. The company says manufacturers will not need to generate extensive validation data themselves; rather they will only need to demonstrate that their machines perform similarly to EOS’ validated process.
“At EOS, we are committed to supporting our customers throughout their regulatory journey,” said Davy Orye, Head of Additive Minds EMEA at EOS. “With the EOS Medical Device Master File, we aim to help manufacturers navigate complex approval processes more efficiently, leveraging years of experience in supporting customers with the medical device approval process and ensuring complete confidence in compliance.”
