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Spain-based EMS firm IKOR has announced that its facility in Mexico has obtained ISO 13485 certification. This follows the company’s ISO 13485 certification for its plant in Spain last year.
ISO 13485 is an international certification for quality management systems for the manufacture of medical devices. The UNE-EN ISO 13485 standard specifies the requirements for a quality management system for the design and development, production, installation and servicing of medical devices, and the design, development and provision of related services.
Achieving ISO 13485 certification is evidence of IKOR’s in-depth knowledge of the medical sector, which is recognized as one of the sectors demanding the most reliable solutions, with stringent technical requirements and also carrying the greatest responsibility.
