Raising the Standard for Biomedical Additive Manufacturing

In biomedical manufacturing, precision is not just a goal. It is a requirement. Whether producing surgical guides, prosthetics, or biocompatible medical components, the slightest inconsistency can mean the difference between a successful outcome and a critical failure. That is why STS Additive Manufacturing operates with clean room precision, ISO-certified processes, and FDA-compliant materials to ensure safe, reliable, and fully validated biomedical solutions.

A Clean Room Designed for Medical-Grade Manufacturing

When working with biomedical resins, surgical components, and implantable-grade materials, contamination is a constant concern. Our ISO 7-certified clean room eliminates airborne particulates and maintains strict environmental controls to meet the highest industry standards. We adhere to cGMP, ISO 13485, and FDA regulations, ensuring that every product is manufactured with the same level of care and precision required for medical and life sciences applications.

End-to-End Biomedical Manufacturing Solutions

STS Additive Manufacturing is more than a 3D printing service. We provide a fully integrated process that ensures regulatory compliance, biocompatibility, and traceability at every stage.

Production

• SLA printing using nine pre-approved Formlabs materials engineered for medical applications
• ISO 13485 compliant processes and documentation
• cGMP compliant processes to meet the stringent requirements of FDA and medical device manufacturing standards

Packaging & Traceability

• ISO 17025-validated procedures for precision packaging
• Serialized product labeling for full traceability and regulatory adherence
• Trusted referrals for biocompatibility testing and validation

Biomedical-Grade Materials That Perform

We specialize in high-performance, biocompatible materials designed to meet the unique needs of medical, dental, and life sciences applications, including:

• Tough 1500 Resin for high-impact medical tools and devices
• Surgical Guide Resin for precise, sterilizable, patient-specific surgical models
• BioMed Resins including BioMed Black, BioMed Clear, BioMed Durable, BioMed Elastic 50A, BioMed Flex 80A, and BioMed White, all designed for biocompatibility and long-term durability

A Smarter Approach to Biomedical Manufacturing

STS Additive Manufacturing is redefining what is possible in biomedical 3D printing. Our clean room facility, validated production processes, and cutting-edge materials ensure that every component meets the highest quality, safety, and regulatory standards.

If your project requires uncompromising precision, biocompatible materials, and fully validated manufacturing, we are ready to help. Contact us today to learn how STS Additive Manufacturing can support your biomedical manufacturing needs.