OUR CERTIFICATIONS

Commitment to Quality, Safety & Excellence

At Fdesia Surgical Instruments, quality is at the heart of everything we do. We are committed to maintaining high standards in the design, manufacture, and supply of our ophthalmic and microsurgical instruments.

Our certifications reflect our commitment to quality management, product safety, and compliance with applicable international requirements.

ISO 13485:2016

Quality Management System for Medical Devices

Our ISO 13485:2016 certification demonstrates our commitment to maintaining a quality management system specifically designed for the medical device industry. It supports our focus on consistent processes, quality control, traceability, and continual improvement throughout our operations.

CE Compliance – Medical Class I

European Market Compliance

Our CE compliance for Medical Class I devices reflects our commitment to meeting the applicable health, safety, and regulatory requirements for products placed on the European market.

Our Commitment

For us, certification is more than a document—it represents our ongoing commitment to delivering reliable, high-quality surgical instruments that meet defined quality and regulatory requirements.

We continuously strive to maintain the highest standards across our processes and products, supporting healthcare professionals and partners with confidence in the quality and consistency of our instruments.

View our certificates below to learn more about our quality and regulatory compliance.