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ISO 13485:2016 CERTIFIED

Regulatory requirements are getting more and more stringent throughout every step of a product’s life cycle, from designing to delivery. Advance Medical now complies to the UNI EN ISO 13485:2016 standard and has been certified by ICIM SPA, one of the major independent certification bodies in Italy. This internationally agreed standard sets out the requirements for a quality management system specific to the medical devices industry.

IQNET CERTIFICATE

The proven quality of our Software is one of the essential requirements for building a relationship of trust with all stakeholders. It reflects our commitment to continual improvement and gives FocalPoints customers confidence in our ability to bring effective products and services to market.

Advance Medical has implemented and maintains a Quality Management System for the scope of “Design, development and sale of FocalPaints software aimed exclusively to the design/manufacturing of Specialty Contact Lenses & Provision of associated services, training. maintenance, SW Validation & Regulatory Consulting Services." which fulfils the requirements of the ISO 13485:2016 standard.