ADDMAN has expanded its ISO 13485-certified quality management system to include its Irvine, California polymer additive manufacturing facility. This builds on our long-standing ISO 13485 certification at our Ontario, New York location, where we have supported medical device manufacturers for years across injection molding, metal additive manufacturing, and high-temperature SLS processes.
By extending ISO 13485 certification to Irvine, ADDMAN increases certified capacity to serve medical OEMs as demand for regulated additive manufacturing continues to scale.
This milestone reinforces ADDMAN’s position as a production-ready advanced manufacturing partner for medical models, instrumentation, device housings, and robotics applications.
What This Means for Our Customers in the Medical Industry
The addition of Irvine to our certified footprint strengthens our ability to:
- Increase production capacity for regulated programs
- Reduce lead times as volumes scale
- Support geographically diversified supply strategies
- Maintain consistent quality system alignment across facilities
For medical manufacturers, this expansion provides broader access to ISO 13485-certified additive manufacturing resources within a unified quality framework.
Our Ontario, NY facility has operated under ISO 13485 certification for years, supporting medical programs that require structured process control, documented traceability, and disciplined risk management. That certification covers injection molding, metal additive manufacturing, and high-temperature SLS — technologies frequently utilized in regulated medical applications.
As demand for polymer additive manufacturing has grown — particularly across medical models, instrumentation housings, and robotic system components — expanding ISO 13485 certification to our Irvine facility was a natural next step.
Continuity from Prototype to Production
Medical additive programs often evolve rapidly — from early development models to validation builds and scaled production. While additive manufacturing has matured beyond a development-only tool, one of the most common friction points in medical additive programs occurs during the transition from early-stage development to validation and production.
By integrating Design for Additive Manufacturing (DfAM), rapid prototyping, validation builds, production volumes, and post-processing within ISO 13485-certified systems, ADDMAN enables continuity throughout the product lifecycle.
Because our Ontario and Irvine sites operate within aligned quality frameworks, programs can scale across facilities without introducing new quality systems or re-establishing compliance infrastructure.
Capacity Matters in Regulated Additive
Additive manufacturing is often perceived primarily as a prototyping solution. However, advances in polymer technologies such as MJF and FDM have made production-scale additive increasingly viable for medical components.
ADDMAN’s manufacturing capacity enables:
- Repeatable batch production
- Documented quality reporting
- Scalable production volumes
- Reduced tooling dependency
- Faster design iteration without requalification delays
For medical device companies managing complex product portfolios, additive manufacturing can serve as both a development accelerator and a flexible production strategy — when supported by appropriate quality systems.
In regulated environments, capacity must be paired with structured quality systems. Certification across multiple facilities strengthens both.
Integrated Post-Processing and Risk Management
Secondary processes and finishing often introduce additional suppliers — and additional complexity — into regulated programs.
ADDMAN provides post-processing and finishing services within its certified framework, helping medical manufacturers keep additive production and secondary operations within one controlled system.
Fewer handoffs mean stronger documentation continuity, simplified supplier oversight, and reduced compliance risk. In regulated programs, integration matters.
Strengthening Our Commitment to Medical Manufacturing
Extending ISO 13485 certification to Irvine represents a strategic investment in expanding regulated additive manufacturing capacity.
With certified infrastructure now spanning:
- ● Injection molding
- ● Metal additive manufacturing
- ● High-temperature SLS
- ● Polymer additive manufacturing, including PolyJet, MJF, and FDM
ADDMAN continues to scale its manufacturing support for its medical device manufacturers operating in highly regulated markets.
As medical technologies continue to evolve, additive manufacturing plays an increasingly important role in enabling complex geometries, rapid iteration, and scalable production strategies.
For OEMs seeking an ISO 13485-certified additive manufacturing partner with multi-facility capacity, integrated post-processing, and production-ready infrastructure, ADDMAN is positioned to support programs from development through compliant production.
LEARN MORE
To learn more about our certified medical additive manufacturing capabilities, contact our team to start the conversation.