- Capacity Expansion: Arterex opens a new 9,000-square-foot ISO Class 8 cleanroom in Tecate, Mexico.
- Enhanced Capabilities: The expansion enables advanced turnkey device manufacturing, precision injection molding, and assembly under strict FDA and ISO 13485:2016 standards.
- Growing CDMO Demand: The strategic investment responds to surging OEM demand for end-to-end medical device contract development and nearshore supply chain solutions.
July 22 2026- Global medical device developer and contract manufacturer Arterex has announced the opening of a new 9,000-square-foot ISO Class 8 cleanroom at its Tecate, Baja California, Mexico, facility. The expansion was completed to meet surging customer demand for high-precision, contamination-controlled medical component manufacturing. As a result, this facility enhancement increases the company’s regional capacity for precision injection molding, device assembly, and secondary processing operations.
The new cleanroom strengthens Arterex’s turnkey manufacturing capabilities. It enables precise joining, bonding, and protective packaging under controlled conditions. The FDA-registered Tecate plant operates under strict ISO 13485:2016 quality standards. Rigorous particulate monitoring ensures consistent quality for critical medical products. This allows Arterex to support OEMs through every production phase, from early design to high-volume manufacturing.
This strategic expansion directly reflects growth trends across the global medical device contract development and manufacturing organization (CDMO) market. As medtech OEMs face heightened regulatory scrutiny and rising operational costs, companies are increasingly turning to specialized CDMO partners to handle complex, capital-intensive manufacturing processes. By expanding its cleanroom capacity in Tecate, Arterex positions itself to capture expanding market share in nearshore contract manufacturing.
This investment reflects an industry shift toward end-to-end outsourcing. In particular, this helps medical device OEMs reduce supply chain risks while maintaining strict compliance. Arterex continues to invest across its global production network. Through these expansions, the company reinforces its position as a trusted manufacturing partner. Ultimately, this helps accelerate time-to-market for life-saving medical devices.
