Advance Medical is now a ISO 13485:2016 certified Company

January 2022 - Go to Certification

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.

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 FocalPoints software aimed exclusively to the design/manufacturing of Specialty Contact Lenses & Provision of associated services, training. maintenance and SW Validation" which fulfils the requirements of the ISO 13485:2016 standard.

Obtaining the ISO 13485:2016 Certification was a great challenge for Advance Medical, but we wanted to put ourselves under the same quality standard of our customers. It was an incredible journey and it was made possible by everyone's passion and by the unique guidance of Ubaldo Fabrizio from EFFETRE, the best QA Consultant we could ever have.

Filippo Selden, CEO of Advance