Aprios Launches ISO Class 8 Clean Room for Precision Medical Device

At Aprios, our goal is to build stronger supply chains for our customers' most critical projects. That's why we're proud to announce the launch of our new, certified ISO Class 8 Clean Room at our facility in Vista, California. Certified on July 24, this facility is a major step in our strategy to serve the state’s booming medical device sector.

What This Means for Medical Device Manufacturers

We know that medical device companies face a unique set of challenges, from tight regulations and demanding quality standards to the constant pressure to innovate. Our Vista Clean Room was designed from the ground up to solve these problems.

The facility features five new JSW electric presses for precision injection molding and is ISO 13485 certified and FDA registered to ensure full compliance. By providing local production in California, we help our partners cut down on supply chain risks and shorten lead times. For our customers, it all adds up to faster, more reliable access to the critical clean-room components they need. Additionally, our DFM for Medical Devices and Injection Molding Services help ensure that each part is optimized for performance and cost-efficiency.

A Milestone in Aprios’ Growth Strategy

The Vista facility is now home to our third certified Clean Room, but it’s the first at this location. Expanding our footprint in California underscores our commitment to being a trusted partner in one of the nation’s fastest-growing hubs for medical innovation.

“Our Vista Clean Room is another important milestone in Aprios’ ongoing growth strategy,” said Alex Danzberger, CEO of Aprios Custom MFG. “By investing in clean room molding capacity, we’re strengthening our commitment to medical device customers and creating essential domestic resources to support their increasingly complex supply chain challenges. Our ISO-Certified Manufacturing and Precise Tooling Solutions are integral to delivering high-quality, reliable products.”

Supporting Innovation in California

California’s medical device industry is thriving, and local resources matter more than ever. By adding clean room injection molding capacity in Vista, Aprios helps medical device teams accelerate product development, ensure quality, and bring life-changing technologies to market.

“Medical device innovation is thriving in California, and Aprios is proud to be a partner in that growth,” said Les Middleton, VP of Sales & Marketing. “Our new Clean Room in Vista allows us to better support our customers with the highest standards of precision injection molding, while creating new opportunities for collaboration. Our Design for Injection Molding (DfIM) capabilities ensure we meet the most stringent standards in product design and manufacturing.”

Ready for New Projects

The Vista Clean Room is now fully operational and open for new customer programs. Whether you’re developing an early-stage prototype or scaling into high-volume production, Aprios offers the flexibility, expertise, and local resources to help bring your product to life. From Medical Device Prototypes to Rapid Prototyping Services, we provide end-to-end Custom Manufacturing Services to support your most critical projects.