USCMA-compliant facility strategically located to meet growing demand for medical device fulfillment and packaging in North America
SINGAPORE, Jan. 27, 2026 /PRNewswire/ — ENNOVI has announced a major expansion of its OCP Tijuana facility in Mexico. The move positions the business as a key player in medical device component fulfillment, including EU MDR[1] and FDA-compliant labeling, packaging, and traceability, offering new solutions to top-tier medical device manufacturers across North America and beyond.
The expansion comes as medical device manufacturers face increasing pressure to streamline supply chains, ensure regulatory compliance, and control costs. ENNOVI’s facility is USMCA-compliant[2], offering a unique advantage: a competitively-priced manufacturing base strategically located near major North American markets. In addition to medical device fulfillment and packaging, the company provides dock-to-stock fulfillment for both industry-standard Ethernet, HDMI and USB cables and custom-designed molded cables and wire harnesses. The company also supplies plastic and metal accessory components sourced from ENNOVI Medical’s global network or other customer-designated suppliers.
“We’re seeing strong demand from medical device OEMs for reliable, cost-effective fulfillment and packaging solutions,” said Theron Mackey, Sr. Director of Business Development at ENNOVI. “By leveraging our expertise in cable assembly and wire harness manufacturing, and expanding into finished accessory components and sub-assemblies, we’re able to deliver significant value to our customers, whether they’re outsourcing for the first time or looking to optimize existing operations.”
ENNOVI has built a long-standing reputation for quality, reliability, and customer service. The company’s robust supply chain, certified testing for mechanical flexibility, electrical performance, and ISO 10993 biocompatibility, ensures that every product meets medical-grade standards. The medical R&D center based in San Diego is certified to ISO 9001:2015 quality management standard. The Tijuana FDA-registered manufacturing facility is certified to ISO 9001:2015 and ISO 13485:2016, UL 764 compliant, and adheres to the IPC/WHMA-A-620[3] workmanship standard.
“Our customers trust us to handle the critical components that keep their medical devices running safely and efficiently,” Mackey added. “This expansion is about giving them even more reasons to connect with confidence and with ENNOVI.”
For more information about OCP-ENNOVI, visit: www.ennovi.com/medical/
About ENNOVI
ENNOVI is an end-to-end customized solutions partner, empowering OEMs to harness AI-driven technologies and accelerate innovation for medical devices. Agency Contact:
Publitek
Erin McMahon
[email protected] [1] https://eumdr.com/
[2] https://ustr.gov/trade-agreements/free-trade-agreements/united-states-mexico-canada-agreement
[3] https://www.whma.org/ SOURCE ENNOVI
ENNOVI is an end-to-end customized solutions partner, empowering OEMs to harness AI-driven technologies and accelerate innovation for medical devices. Agency Contact:
Publitek
Erin McMahon
[email protected] [1] https://eumdr.com/
[2] https://ustr.gov/trade-agreements/free-trade-agreements/united-states-mexico-canada-agreement
[3] https://www.whma.org/ SOURCE ENNOVI
Source link
Leave a Reply