ENNOVI Expands Its Tijuana Facility to Boost Medical Device Production

ENNOVI's Strategic Expansion in Tijuana



ENNOVI has made headlines with its recent announcement regarding the expansion of its OCP facility located in Tijuana, Mexico. This strategic move positions ENNOVI to become a critical player in meeting the rising demand for medical devices, specifically in the areas of fulfillment and packaging. With the medical device industry under increasing pressure to streamline operations, ensure compliance with regulatory standards, and minimize costs, this expansion could not come at a better time.

The facility in Tijuana is compliant with USMCA regulations, which gives it a competitive edge as a manufacturing base in close proximity to major markets across North America. ENNOVI’s expansion is essential not just for its operations but for its customers as well. As medical device original equipment manufacturers (OEMs) demand more reliable and cost-effective solutions, the Tijuana facility offers a comprehensive range of services, including the fulfillment of medical device components with EU MDR and FDA-compliant labeling and traceability.

According to Theron Mackey, Senior Director of Business Development at ENNOVI, there is a noticeable increase in demand from medical device manufacturers for dependable fulfillment and packaging services. He notes that by leveraging their expertise in cable assembly and wire harness manufacturing, ENNOVI can provide added value to customers, whether they are outsourcing for the first time or looking to optimize their current operations.

In addition to medical device fulfillment and packaging, the Tijuana facility offers dock-to-stock fulfillment services for standard Ethernet, HDMI, and USB cables, in addition to custom-designed molded cables and wire harnesses. ENNOVI also sources plastic and metal accessory components through its vast global network, ensuring that customers have access to a diverse range of high-quality products.

Quality and reliability have always been hallmarks of ENNOVI’s operations. The company implements a robust supply chain and offers certified testing for mechanical flexibility, electrical performance, and ISO 10993 biocompatibility. This ensures that all products manufactured at the Tijuana facility meet stringent medical-grade standards. Additionally, the facility's FDA registration and ISO 9001:2015 and ISO 13485:2016 certifications, along with UL 764 compliance, demonstrate a commitment to high manufacturing standards.

The expansion of the Tijuana facility reaffirms ENNOVI's aim to enhance its reputation for quality and customer service. Mackey stated that the company is dedicated to managing critical components that keep medical devices operating safely and efficiently. This growth initiative will provide even more reasons for clients to engage confidently with ENNOVI.

As the demand for medical devices continues to advance, ENNOVI’s expansion efforts in Tijuana represent a proactive approach to enhancing production capabilities and compliance standards in the medical sector. The company is not just expanding its physical footprint but is also reinforcing its role as a trusted partner for medical device manufacturers across North America and beyond.

For more information on ENNOVI’s offerings and services, visit ENNOVI’s Medical Division Website.

Topics Business Technology)

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