The medical device market faces increased pressure to meet rising demand for medical devices, and those intricate devices demand for specialised engineering knowledge and expertise to ensure product success in critical environments. That’s why at FermionX we’re looking to enhance our capabilities and production growth for our customers by being ISO 13485 certified. 

Our ISO 13485 certification serves 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.

But, what are the further advantages of choosing an ISO 13485 certified CEM for your business? 

At its core, ISO 13485 is all about ensuring that medical devices are safe and effective for patient use. One key way to achieve this is by implementing strict EPA (Electrostatic Protected Area) protocols, which minimise the risk of electrostatic discharge (ESD) damage to sensitive components in medical devices.

At FermionX, we have implemented access control testing measures, including badge identification and activity logging. ESD lab coats, shoes, heel straps and wrist protection have been provided to all staff, and visitors must also comply with at least one form of protection to enter the production facility. To ensure climate control, air conditioning has also been put in place in the main production areas of our premises’.

These measures help to ensure that only authorised staff are allowed into the EPA and that all activity is tracked and monitored. By doing so, we can identify and address any risks of defects before they can impact the quality of your products. This not only results in less rework and waste, but also provides you with trust that your product will succeed in any environment.

Common doubts customers can have is knowing whether the CEM they outsource to buys from reputable sources and suppliers, has a controlled build process, and the right information to build the product.

At FermionX, we aim to foster trust and accountability throughout the manufacturing lifecycle by investing in a new ERP/MRP system to enhance overall quality processes, traceability, and reporting. This system spans the whole business and plans out production timelines and provides transparency in sourcing components and their origins. 

You can be confident that components and materials used in the production process are of the highest quality and reliability, thanks to our solid relationships with suppliers. Not only can our team stay updated on the latest information, but they can provide you with evidence on where exactly we are with supply.

As a manufacturer, it’s important to keep customers informed about their production status. However, with the increasing complexity of supply chains, it can be challenging to provide real-time updates. 

Customer satisfaction is the driving force behind our commitment to delivering high quality products. Therefore, we can provide you with a complete overview of your production status, from start to finish. 

Customers can easily gain key information, such as where their job is within production. As you will always be in the loop, you can trust that your production is on track – while we can focus on delivering the highest quality standards.

If you’re in the medical device industry, you know that manufacturing can be a complex and time-consuming process. But what if you could channel your efforts into your core capabilities – like research and development – while leaving the manufacturing to us?

We understand that not everyone has the resources or expertise to handle the intricacies of medical device manufacturing. That’s why we offer our services to companies looking to outsource their manufacturing requirements and scale up their production. With our experience and expertise, we handle every aspect of the manufacturing process, saving time and resources while helping to get products to market faster.

By partnering with an ISO 13485 certified CEM that is committed to strict protocols and process controls, you can have complete peace of mind knowing that uncompromising quality, traceability, and safety are guaranteed in every product delivered. 

As the certification ensures that our manufacturing processes are up to international standards, this can provide you with broader market access and collaboration opportunities globally.

Our team is dedicated to continuous improvement and customer satisfaction. With proper maintenance and aftercare, we can ensure that your products will succeed in any environment and continue to operate for years to come.

We’re dedicated to providing high-quality support to the demands of the medical manufacturing industry. Get in touch with us today to learn more about our commitment to quality and how we can support your needs.

01903 524600