Medical Device Sterilisation – Part of the Concept to Completion Service
Management Services and Validation
Medical Product and Equipment Sterilisation Capabilities
We provide a complete medical device development service, from initial prototyping to testing and packaging. One facet of this service is our contract medical equipment and device sterilisation.
As part of our comprehensive medical device development services, we offer a range of sterilisation methods and equipment including Ethylene Oxide (EO), Gamma and Auto Clave sterilisation. These forms of medical sterilisation are universal and account for a large majority of requirements and certification needs.
We offer sterilisation as part of our complete medical device development process and not as a standalone service. By doing so, we ensure our skilled team can advise and undertake every aspect of the process from design to sterilisation, and development to validation.
Medical device sterilisation is only one aspect of the complete Europlaz service and is carried out by trusted partners with expertise in medical-grade sterilisation allowing for accurate control and monitoring of air particulates and other matter. By working with Europlaz you can ensure your product is well-designed, built for purpose, and produced and packaged in a safe environment.
We are also a registered FDA Medical Equipment Manufacturer and provide high-quality medical device manufacture to an ISO13485 standard. With all of this to our name, you can trust your medical equipment, product, or device sterilisation with Europlaz.
Advanced Medical Device Sterilisation to Support the Europlaz Process
The Europlaz medical product sterilisation process needed for your device will be taken into consideration from the very start of the design process to ensure packaging, materials and processes comply with sterilisation needs.
We include medical equipment and device sterilisation management as part of our process and devices are tested vigorously before and after sterilisation before they are despatched to any customer or end-user. This approach ensures that your products perform to a high standard and are safe for all medical applications.
Please note that medical sterilisation is only available as part of a project and not a standalone service. For more information on our services, or to find out how we can help you design and manufacture your medical product or device contact us today.
Packaging of Sterile Medical Devices
Once we have assisted you with design, development, and manufacturing we can then ensure your product is packaged and delivered safely. We offer packaging in pouches or trays prior to sterilisation as well as kitting after sterilisation. Medical devices will arrive at the final customer/destination sterile and ready for use.
We can assist with:
- Selection of contract sterilisation location
- Validation protocol preparation, and execution
- Re-validation activities
- Product processing activities
All of this is part of our complete package providing you with a single, seamless development partner from design to delivery.
Since 1970 we have built a reputation for innovation, quality, and cost-effectiveness.
We use our experience and state-of-the-art technology to streamline all stages of the medical device manufacturing process for you – moving your product quickly and safely through development, and speeding up regulatory approval of medical devices.
Our UK-based ISO 13485 certified and FDA-compliant facility means that we have complete control of the process, from under one roof. We are flexible, and resourceful, and can take on projects of any size. Our clients range from small start-ups to international blue chip medical device suppliers.