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IKOR Achieves ISO 13485 Quality System Certification for Medical Device Manufacturing

We are pleased to announce that IKOR and our centre for design and development, IKOR Technology Center, just received the ISO13485* international certification for quality management systems for the manufacture of medical devices, thus becoming the first Spanish EMS to receive this international certification.

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

Achieving ISO 13485 certification is evidence of IKOR’s in-depth knowledge of the medical sector, which is recognised as one of the sectors demanding the most reliable solutions, with stringent technical requirements and also carrying the greatest responsibility.

Our strategy is to support customers in technologically demanding and cutting-edge sectors of this type, and for this it is necessary for the group to continually adopt, learn and demonstrate its capabilities.

For IKOR this represents the fulfilling of one of the main objectives set last year and brings it closer to also obtaining the certification of its plants in Mexico and China.

Our next objective will be the certification of design and manufacturing process according to the FDA regulations (the American agency that regulates medical devices) so that the customers in the electromedical sector can market their products in the USA.

*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.

For more information about the UNE-EN-ISO 13485 standard click here

IKOR, 22 February 2016