EpiGuard has been ISO 13485:2016 certified!

We are proud to announce that EpiGuard is ISO 13485:2016 certified!

It is official! EpiGuard has received a prestigious ISO 13485:2016 accreditation. This achievement is a testament to Epiguard’s comprehensive quality system and our commitment to providing medical equipment and supplies that are safe for patients.

The medical device manufacturing industry is one of the most regulated sectors. The regulatory requirements in this sector ensure that manufacturers consistently design, produce, and place the safest possible medical devices onto the market.

What is ISO 13485:2016?

ISO 13485:2016 is the standard for a Quality Management System (“QMS”) for the design and manufacture of Medical Devices. It specifies requirements for quality management systems for medical devices, including design control and risk management. It is also a strong foundation for manufacturers like EpiGuard to address their responsibilities and demonstrate a commitment to the safety and quality of medical devices they produce.

Why do we need ISO 13485:2016?

ISO 13485:2016 is an internationally recognised accreditation for any manufacturer who is looking to improve quality and consistently meet safety requirements. It provides us and our customers with evidence that we have all the standards in place and that we are committed to safety and quality of all our medical devices.

How did we achieve the certification?

It has been a long road. We started back in 2019 with the process of re-evaluating the quality system to implement changes that will help us maintain our commitment to medical device safety and quality. This involved an extensive review of our overall management system and processes. The process was completed in September 2021, and we have been working with our partners to ensure that our manufacturing practices meet all the requirements outlined by ISO 13485:2016.

Our ISO certification is just one more way to show our hard work and dedication to deliver on our promise to provide innovative solutions that are safe, high-quality, and effective.

bsi iso certification paper

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