KRAILLING, Germany, May 5, 2025 – EOS has introduced the “Medical Device Master File”, offering prevalidated technical data to support regulatory compliance for medical device manufacturers while maintaining confidentiality of proprietary information.
Regulatory compliance in the United States requires testing, documentation, and working with government agencies, which can cause delays. The EOS Master File allows manufacturers submit Intellectual Property (IP) to medical regulators. This supports compliance while protecting proprietary data. The master file also acts as a shared reference for multiple device manufacturers, streamlining approvals and speeds time to market.
With over twenty years of experience in medical device manufacturing, EOS has established itself as a trusted partner in additive manufacturing for medical applications. The EOS M 290 metal AM platform is recognized for producing approved medical devices such as hip cups, tibial trays, and spinal cages.
EOS Medical Device Master File: A Resource for Medical Manufacturers
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 minimizes delays in market entry.
- Prevalidated process and material data: The master file ensures that critical parameters have been assessed and approved
- Faster time to market: By referencing the EOS Master File, manufacturers can avoid redundant verification processes, shortening approval timelines
- Reduced testing: Manufacturers do not need to generate validation data; they 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.”
Source: EOS
About EOS
EOS GmbH Electro Optical Systems, founded in 1989 and headquartered in Krailling near Munich, Germany, is a provider of industrial 3D printing solutions. The company specializes in additive manufacturing systems for metals and polymers, serving industries such as aerospace, automotive, medical technology, and toolmaking. EOS offers a portfolio that includes 3D printers, materials, software, and consulting services to support end-to-end additive manufacturing processes. As of 2022, EOS reported consolidated revenues of approx. €360.3 million and employed around 1,420 people worldwide. The company operates in over 15 countries, providing responsible manufacturing solutions to a global customer base. EOS is recognized for its role in the development and commercialization of laser sintering technologies, contributing to the advancement of additive manufacturing.