EOS solves huge medical 3D printing certification problem with a regulatory-ready master file
The Atomic Layers: S9E29 (00266)
Atomic Layer of the Day:
Anyone who has had real experience in the medical industry — meaning they've produced more than just a “prototype” or a “demo model” — knows that one of the biggest challenges is obtaining regulatory approval to bring a given application into use or to market.
It’s a tedious and costly process that requires not only a high level of technical excellence but also preparation of detailed compliance documentation in line with applicable standards.
Regulatory procedures, while essential for patient safety, are a significant barrier for manufacturers.
They demand months of testing and constant cooperation with certification agencies, generating high costs and delaying access to treatment.
However, to address these challenges, EOS has developed and made available a Medical Device Master File — a complete, validated documentation package covering the 3D printing process and materials, which has already been assessed for compliance with regulatory requirements, including those of the U.S. FDA.
Medical device manufacturers using EOS systems and materials can refer to the data included in this documentation instead of conducting their own validation studies.
This eliminates the need for different entities to repeat the same tests, saving both time and resources. At the same time, the system protects companies' intellectual property — sensitive information is disclosed only to regulatory authorities, with no risk of exposure to competitors.
But the benefits go beyond cost and procedural simplification. A shortened certification path means faster deployment of implants such as hip cups or spinal stabilizers. For the AM sector, this represents an opportunity to expand its potential — particularly in design flexibility and medical personalization.
EOS’s experience with regulatory agencies plays a key role here. Having operated in the medical sector for over 20 years, EOS is already well-versed in legal and compliance matters.
The Medical Device Master File is also strategically important for EOS itself. With this type of solution, the company builds a significant competitive edge over manufacturers of similar 3D printing systems from Asia. Initiatives like this allow EOS to provide genuine added value that goes beyond just the printing technology.
Ultimately, the introduction of such frameworks marks a step toward the maturity of the entire additive manufacturing industry. Standardization and data sharing can accelerate the adoption of 3D printing in medicine — making it not just an alternative, but a primary method of production.
Atomic Layer from the Past:
04-29-2020: Stratasys introduced the J55.
News & Gossip:
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Apologies for delayed article, but Substack had a major outage today, and even when it started working again, there were serious issues with sending emails. So, forgive me—force majeure...