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Ikor achieves ISO 13485 certification

Ikor, a Spanish EMS provider based in San Sebastian, and its centre for design and development, the Ikor Technology Center, has received the ISO13485 international certification for quality management systems for the manufacture of medical devices.
“The ISO 13485 proves our commitment to offering added value in a systematic, predictable and verifiable way to our customers in the medical devices market”, according to Jon Sierra, CEO of Ikor. “This certification is a reflection of the significant investment in quality systems required for the manufacture of medical devices and paves the way for Ikor to significantly expand its medical device manufacturing services business."

Ikor and the Ikor Technology Center have adapted their processes for the design and development of new products and their manufacturing processes in accordance with this standard, which involves the introduction of comprehensive control measures to satisfy the requirements of the medical sector.

The next goal for Ikor is to certify its design and manufacturing process according to the FDA regulations (the American agency that regulates medical devices).


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