EOS Medical Device Master File helps accelerate regulatory approvals for AM manufacturers
May 1, 2025
EOS GmbH, headquartered in Krailling, Germany, has announced its latest advancement in regulatory compliance support for medical device manufacturers. The EOS Medical Device Master File provides pre-validated technical data, helping streamline the regulatory approval process while protecting proprietary information.
TRUSTED CONTENT. TARGETED AUDIENCE
Advertise with Metal AM and access a global base of 50,000+ AM professionals
| Contact us |
“At EOS, we are committed to supporting our customers throughout their regulatory journey,” stated 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.”
Regulatory compliance often 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.
The EOS Master File is designed to help expedite regulatory approval by offering a single, validated source of technical data. This reduces repetitive testing, lowers regulatory friction, and minimises delays in market entry.
The Master File ensures that critical parameters have been assessed and approved. By referencing the EOS Master File, manufacturers can avoid redundant verification processes, significantly shortening approval timelines. Additionally, manufacturers do not need to generate extensive validation data themselves; they only need to demonstrate that their machines perform similarly to EOS’ validated process.
