Certifications
Unwavering Dedication to Quality
Desio contact lenses epitomize our unwavering commitment to quality and safety, serving as the bedrock of our dedication to excellence. Moreover, holding both CE marking and FDA approval, they adhere to rigorous medical standards, ensuring users’ confidence in their reliability and efficacy. Additionally, our company proudly holds certifications to ISO 13485 for the design, manufacturing, and marketing of medical devices, contact lenses, and solutions. Furthermore, this certification, with our CE marking and FDA approval, emphasizes our meticulous approach. It guarantees that our products meet the highest standards of quality and safety.
Innovative Lens Design
At the core of our innovation lies our patented lens design, distinguishing us in the industry and reflecting our relentless pursuit of perfection. Additionally, this groundbreaking design, combined with our brand’s registration in over 100 countries worldwide, underscores our global recognition and reach. Additionally, Desio lenses are consistently praised for their unmatched reliability and quality. They also offer clear vision, comfort, and clarity, enhancing users’ daily lives worldwide.
Continuous Improvement
In addition, our commitment to continuous improvement remains steadfast. We invest in ongoing research and development to integrate cutting-edge solutions and technologies into our products, ensuring that we stay ahead of the curve in the industry. Through meticulous attention to detail and adherence to stringent certification processes, we uphold our reputation as a trusted leader in the contact lens market.
Customer-Centric Focus
With every Desio contact lens, we aim not only to provide vision correction but also to instill confidence, comfort, and clarity. Moreover, it is our privilege to serve our customers, and we remain resolute in our commitment to delivering the highest quality products and services.
IEN ISO 9001:2015
It is the internationally recognized standard for business quality management and applies to the processes that create and control an organization’s products and services.
It prescribes systematic control of activities to ensure that customer needs and expectations are met.
EN ISO 13485:2016
It specifies the requirements for a quality management system where an organization must demonstrate its ability to provide medical devices and related services that meet customer needs and applicable regulatory requirements for medical devices and related services. The primary goal of EN ISO 13485:2016 is to facilitate the medical device’s compliance with regulatory requirements for quality management systems.
CE Mark
A mandatory conformity mark for products placed on the market in the European Economic Area (EEA). With the CE marking on a product, the manufacturer ensures that the product complies with the essential requirements of the applicable CE directives.
FDA 510k
The Food and Drug Administration (FDA or USFDA) is the agency of the United States Department of Health and Human Services. It is the FDA’s responsibility to protect and promote public health. An FDA certificate ensures that a product meets the US FDA requirements for medical devices sold in the United States.
- SDFA Saudi Arabia – Food and Drug Authority
- CAPA Approval
- Egypt Medical Advice Registration
- Medical Device Registration in the UAE
- AMAR- Medical Device Registration and Approval in Isreae
- DMP Approval – Marocco Medial device registration
- ANMAT – The National Administration of Drugs, Foods and Medical Devices in Argentina
Certificate of Free Sale issued by the Italian Ministry of Health.
Local certifications have been obtained in the respective foreign countries.