FermionX Manufacturing achieves ISO 13485 certification for medical device manufacture

Source: Fermionx

23 January 2024

The medical devices market faces increased pressure to meet rising demand for medical devices, and those intricate devices demand for specialised engineering knowledge and expertise to ensure success in critical environments. FermionX Manufacturing is dedicated to enhancing our capabilities and production growth for our customers. We’re proud to announce that we have recently achieved ISO 13485 certification, the globally recognised Quality Management standard for medical device manufacture.

To demonstrate our dedication to delivering the highest quality standards and customer satisfaction, we have made significant improvements to our premises, resources, and internal processes. These changes serve as a hallmark of our commitment towards delivering the highest quality standards. Reducing product risks, improving traceability and ensuring safe and reliable medical devices that are backed by rigorous quality controls.

At its core, ISO 13485 is all about ensuring that medical devices are safe and effective for patient use. As an electronic contract manufacturer that prioritises quality and safety, we’ve implemented stringent ESD (electrostatic discharge) measures to our premises, air conditioning systems, and investment in a new ERP/MRP system. Our certification assures our customers of uncompromising quality, traceability, and safety in every product we deliver.

Additionally, we provide customers with a complete overview of production status from start to finish. This ensures they are always in the loop and can focus on their core capabilities - like research and development - while leaving the manufacturing in our capable hands. With the correct maintenance and aftercare, we can ensure that your products will continue to operate effectively for years to come.

Get in touch with us today to learn more about our commitment to quality and how we can support your manufacturing needs.

T. 01903 524600
E. sales@fermionx.com
W. www.fermionx.com