KEENFINITY EMS Unlocks Medical Technology Potential through ISO 13485 Certification

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The KEENFINITY Electronics Manufacturing Services (EMS) plant in Ovar, Portugal, has been awarded ISO 13485:2016 certification for medical technology. The certification covers the design and manufacturing of electronic systems such as control units, power supply units, or human–machine interfaces for a broad range of medical devices.

Whether diagnostic systems, patient‑monitoring equipment, vital‑sign measurement technologies, or wearables – the medical technology sector is one of the most demanding industries, defined by strict regulatory requirements and high-quality standards. This certification reflects KEENFINITY’s core competencies and high standards at the Ovar site and provides access to one of the most significant growth markets worldwide. Moreover, the expansion of electronics manufacturing in Portugal strengthens the European technology ecosystem.

“The Ovar plant is the Center of Excellence within our global production network, driving growth by expanding into highly regulated markets such as medical,” says Ram Dornala, CEO of KEENFINITY EMS. “As we strive to be our customers’ strategic partner across the whole product lifecycle, we are continuously elevating our capabilities, expanding capacities, and strengthening collaboration and competitiveness.”

In December 2025, the Ovar plant expanded its production area to create additional space for Research & Development (R&D) as well as production, underscoring the company’s commitment to growth and value creation in electronics innovation and manufacturing.

In addition to the site in Portugal, KEENFINITY will also apply for medical technology certification for its location in Zhuhai, China. This will enable customers to regionally scale the production of electronic medical devices with agility.