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ISO 13485.

Service in medical device certification, focused on quality, compliance and ISO 13485.

ISO 13485 strengthens consumer trust and access to new national and international markets.

ISO 13485 certifies the Quality Management System for medical devices and is based on meeting the requirements of companies involved in the design and development, manufacturing, packaging, manual preparation, installation or maintenance of medical products. It also includes risk analysis, traceability and sterilized production.