MEDICAL & CERTIFICATIONS

Medical Expertise & Certifications


DrLuigi footwear is classified as a medical device and is sold through pharmacies and orthopaedic stores.
Our products are used both for treatment and prevention of common foot disorders.

The company and its products are certified according to MDD, ISO 9001 and ISO 13485 standards, valid for the EU and US markets.

CE Certification of Medical Supplies

Certificate 93/42 CEE

Coordinated with European Directive on medical devices

Certificate ISO 9001:2001

International standard on quality management system

Certificate ISO 9001:2015

International standard on quality management system

Standard ISO 13485:2003

coordinated with client’s needs and with the applicable regulations

Standard ISO 13485:2016

coordinated with client's needs and with the applicable
regulations

Standard CE EN ISO 20347:04

coordinated with basic and additional requirements for occupational footwear

European Directive 89/686/CEE

coordinated with essential safety requirements in the form of preserving health and safety at work (natural material that doesn’t harm human health)

Certificates EN ISO 14184-I, EN 14632-I, EN ISO 3071, ISO 17694, EN 13512, EN ISO 17700, ISO 17696, EN 13522, EN ISO 17707, ISO 20871, EN 12770