Manufacturing & Regulatory

Alverix has full turnkey manufacturing capabilities that are in accordance with all FDA cGMP requirements. The design team is located in San Jose, California and follows a methodology that matches the FDA 21 CFR 820 elements. The product development team transfers the design from prototype phase to volume manufacturing. 

Manufacturing services are established at our facility in Penang, Malaysia.   The Penang team handles the full manufacturing spectrum, from vendor selection, reliability testing, system documentation, production planning, returns failure analysis and CAPA activities.

Alverix Penang directs all operations at our selected Contract Manufacturing site.  The Contract Manufacture is ISO 13485 certified, cGMP compliant and ROHS compliant. The manufacturing operation is designed to be scalable from low volume prototyping to high volume production.

Contact Information

Beverly Cormier
VP Business Development
(619) 318-0303