Biomedical Manufacturing Requires Perfection

There’s a margin for error in a lot of industries. But not in biomedical manufacturing. A fraction of a millimeter. A minor inconsistency in material composition. A shift in environmental conditions during production. Any of these could be the difference between a successful medical procedure and a critical failure.

This isn’t about getting it right most of the time. It’s about getting it right every time.

At STS Additive Manufacturing, we don’t just print medical components. We engineer solutions in a controlled, ISO 13485 / FDA-compliant environment, ensuring every piece meets the highest standards of safety, precision, and biocompatibility. Because in medicine, there’s no room for “almost.”

A Clean Room Designed for Medical-Grade Manufacturing

When you’re working with biomedical resins and surgical components, contamination isn’t just a concern—it’s a threat.

That’s why we operate in a certified ISO 7 clean room where airborne particulates are minimized, environmental conditions are tightly controlled, and every process meets cGMP, ISO 13485, and FDA standards.

In simple terms? Our facility is built for medical precision from the ground up. Every part, every process, every time.

Beyond Printing: Fully Integrated Biomedical Manufacturing

STS Additive Manufacturing isn’t just about 3D printing medical parts. It’s about full-scale biomedical manufacturing, covering every stage of production, packaging, and regulatory compliance.

Production Capabilities:

• SLA printing using nine pre-approved Formlabs materials designed for medical applications.
• ISO 13485 compliance, ensuring rigorous quality control.
• cGMP-compliant processes, aligning with FDA and medical device standards.

Packaging & Traceability:

• ISO 17025-validated packaging procedures to maintain sterility and integrity.
• Serialized product labeling for full traceability and regulatory compliance.
• Trusted referrals for biocompatibility testing & validation.
• Packaging only services available upon request.

Biomedical-Grade Materials That Perform

The materials we use aren’t just strong—they’re engineered for life-saving applications.

• Tough 1500 Resin – Designed for high-impact medical tools and devices.
• Surgical Guide Resin – Biocompatible, sterilizable, and ideal for patient-specific surgical models.
• BioMed Resins – Including BioMed Black, Clear, Amber, Durable, Elastic 50A, Flex 80A, and White, all designed for long-term durability and patient safety.

This is the Future of Biomedical Manufacturing

Precision isn’t enough. Validation matters. Biocompatibility matters. Control matters.

At STS Additive Manufacturing, we redefine what’s possible in medical 3D printing—because we know that lives depend on what we do.

If you need biomedical components that meet the strictest regulatory standards, we’re ready to help. Reach out today, and let’s build something that makes a difference.