About Us
Built on Precision. Trusted by Medicine.
For over 15 years, Altus Direct Healthcare Inc has been the trusted partner for medical device marking, surgical instrument identification, and compliant product supply — serving leading institutions across the globe.
Our Mission
Advancing Patient Safety Through Compliance
At Altus Direct Healthcare Inc, we believe that precision marking and reliable supply are not just operational necessities — they are patient safety imperatives. Every device we mark, every label we produce, and every product we supply contributes to a traceable, accountable medical supply chain.
Founded in Santa Ana, California, we have grown from a regional marking specialist into a globally trusted partner for hospitals, surgical centers, and medical device manufacturers across more than 40 countries.
Precision First
Every mark, label, and product we deliver is held to the highest standards of accuracy and consistency.
Regulatory Expertise
We stay ahead of evolving global regulations so our clients never have to worry about compliance gaps.
Partnership Mindset
We work as an extension of your team — responsive, accountable, and invested in your success.
Full Traceability
Every engagement comes with complete documentation, audit trails, and certificates of conformance.
Compliance & Quality
Certifications & Regulatory Standards
Our operations are built around the most rigorous quality and regulatory frameworks in the medical industry.
ISO 13485 Certified
Our quality management system meets the international standard for medical device manufacturing and supply.
FDA-Registered Facility
Registered with the U.S. Food & Drug Administration for medical device marking and supply operations.
UDI Compliant
Full compliance with FDA Unique Device Identification requirements and EU MDR/IVDR marking regulations.
EU MDR & IVDR Ready
Marking and labeling solutions aligned with the European Medical Device Regulation and In Vitro Diagnostic Regulation.
Our History
15 Years of Growth
Founded in Southern California with a focus on surgical instrument marking.
Achieved ISO 13485 certification and expanded into compliance labeling.
Launched custom medical product supply division serving 50+ hospital systems.
Expanded internationally — now serving clients across North America, Europe, and Asia-Pacific.
Became fully UDI and EU MDR compliant ahead of regulatory deadlines.
Surpassed 500 active medical clients with a 98% retention rate.
Partner With Altus Direct Healthcare Inc
Join 500+ medical institutions that trust us for precision marking and reliable supply.