EDAC POWER Obtained ISO 13485:2016 Certification for Medical Device Quality Management Systems

In March 2025, EDAC POWER officially obtained the ISO 13485:2016 certification for Medical Device Quality Management Systems, signifying the company’s compliance with international standards in quality management, risk control, and process stability. This milestone further reinforces EDAC POWER’s longstanding foundation in the medical sector and marks a key step forward in its global expansion into healthcare markets.

ISO 13485 is a globally recognized standard that governs quality management systems for medical devices. It establishes stringent controls and risk management procedures across all stages of a product’s lifecycle—from design and development to manufacturing, installation, and after-sales service. EDAC POWER’s successful certification reflects its unwavering commitment to quality excellence, regulatory compliance, and product safety.

EDAC POWER has a proven track record in the design and manufacturing of high-reliability power solutions, with products widely deployed in medical equipment such as patient monitoring systems, blood analyzers, dental devices, mobile carts, respiratory care systems, and home healthcare applications. To meet diverse application needs, EDAC POWER offers a wide range of power architectures and wattage options, including:

• External Medical Power Adapters: Supporting power outputs from 4.5W to 500W, ideal for a broad range of medical devices.
• Open-Frame Medical Power Supplies: Offering 30W to 500W power ratings, available in multiple industry-standard form factors to enable flexible system integration.

All EDAC POWER medical-grade power products are designed to meet international safety standards such as IEC 60601-1, ensuring compliance with clinical and home-use requirements for safety and electromagnetic compatibility (EMC). These certifications help customers accelerate their time-to-market and reduce development cycles for medical applications.

As global aging continues to drive increased demand for medical services, EDAC POWER is actively expanding its medical product lines to enhance system integration capabilities and overall reliability. The successful attainment of ISO 13485:2016 not only validates the company’s robust quality management system but also strengthens internal operations and supply chain efficiencies, further earning the trust of international medical customers and partners.

Driven by innovation and a pursuit of excellence, EDAC POWER remains committed to delivering safer and more reliable power solutions—empowering the medical industry with intelligent, dependable technologies that support a healthier future.