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8 September, 2021

MARNYS obtains ISO 13485:2016 certification for medical devices

The application of this standard ensures the quality and safety of the product, complying with the regulations in force.

iso 13485:2016

MARNYS® - Martínez Nieto, S.A. has obtained ISO 13485:2016 certification for medical devices. The implementation of a Quality Management System in accordance with this Standard ensures the quality and safety of the product, demonstrating the existence of quality procedures to provide safe and effective medical devices, as well as complying with the requirements of current regulations.

A Quality Management System in accordance with ISO 13485:2016 provides:

  • Comprehensive control of production at the design, manufacturing, and distribution stages of the medical device.
  • Risk management and analysis, ensuring the minimisation, prevention, recording, remediation, and notification of any safety risk associated with the design, development, manufacture, and marketing of the medical device.
  • Implementation, control and monitoring of the post-marketing surveillance system for the medical device.


The research, development, and manufacture of MARNYS® - Martínez Nieto, S.A. products is carried out through innovative and highly controlled processes, and under strict quality and food safety standards recognised worldwide and in accordance with current legislations.

Thus, the company has certifications such as GMP (Good Manufacturing Practices), ISO 9001, ISO 13485, ISO 22716, IFS FOOD, or registration and validation of the plant by the American FDA (Food and Drug Administration). In the MARNYS® cosmetic line, around twenty products are also certified BIO and Natural according to the COSMOS Standard by British Soil Association, in its two categories: COSMOS NATURAL and COSMOS ORGANIC.

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