FermionX achieves ISO 13485 certification for medical device manufacture

As the healthcare landscape in the UK faces the dual challenge of an ageing population and increasing prevalence of chronic diseases, the medical device industry is more under pressure than ever before.

While the demand for these intricate devices is growing, so is the need for specialised engineering knowledge and expertise to ensure they are manufactured to the highest quality standards.

At FermionX, we are proud to announce that we have recently achieved ISO 13485 certification, the internationally 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.

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.