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  • Writer's pictureMonica Giudice

Occuity achieves ISO 13485

Updated: Nov 22, 2021

We could not be more pleased to announce that we just got the ISO 13485 certification!

What is ISO 13485?

ISO 13485 is a Quality Management System specifically developed for the manufacture of medical devices. Its main objective is to help facilitate regulatory requirements in the medical devices industry. It contains a comprehensive list of specific requirements that Occuity needs to follow in relation to how we manufacture our devices to ensure that each product is safe once on the market.

What it means?

ISO 13485 is the internationally recognised gold standard for quality in the medical device industry and certification shows our clients and customers that we take quality very seriously here at Occuity. Our quality management system is based on a set of principles., An important one is customer satisfaction, where we strive to best meet customer needs and expectations. Occuity uses the process approach outlined in ISO 13485 making it much easier to discover opportunities for improvement and creating a culture of continual improvement. As the international standard for Quality Management Systems in the medical device industry, ISO 13485 has been well tested and proven. Now that Occuity have achieved certification, we can show our clients and customers that we comply with best practices, and with regulatory requirements.

Why is it important?

ISO 13485 aligns its requirements to match those of the FDA and other international regulators and has become a staple necessity for organisations wanting to supply safe and regulated medical devices in a competitive market. Becoming certified involves developing a management system based around product policy and quality manual. Occuity receiving ISO13485:2016 certification means that we have been independently audited to ensure that our established processes and procedures meet both customer and regulatory requirements to ensure efficient and safe delivery of products and services.

This is an important proof of our culture of continuous improvement and, in particular, another big step closer to our end goal of changing the life of million of people.

To discover our innovative product pipeline, check out our website here

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