Medical Device Research, Design, and Manufacturing Service
In addition to our existing contract manufacturing services, Europlaz offers clients advanced stage medical device R&D spaces. This offering is suitable for clients who are undertaking advanced stage Research and Development (R&D) work on new medical devices and require the facilities and services of a regulated manufacturing service but are not yet ready for commercial manufacture. This medical device research and development work works alongside our design options to give you access to a complete product development cycle in one service.
Our medical device R&D service offers you the opportunity to continue to develop your product and manufacturing methods with the input of a certified ISO 13485:2016 manufacturer to ensure there are no costly or time-consuming obstacles once you are ready to transfer to commercial manufacture.
Design and Development Validation in Advanced Medical Devices R&D Space
When developing a medical device, design and development validation must be performed to ensure the product can meet the requirements for the specified application or intended use.
By using Europlaz’s comprehensive design and medical device R&D facilities, design validation can be conducted on representative products which can include initial production units, batches or their equivalents.
Work within our facilities to perform clinical evaluations or performance evaluations of medical devices in accordance with regulatory requirements.
Validation must be completed prior to release for use of the product to the customer and records and results of the validation maintained.
The facilities we have available to rent include:
Dedicated medical device R&D laboratory space with access to design, assembly and measurement equipment including injection moulding, ultrasonic welding, bonding and 3D printing.
Access to our select group of engineering partners.
Transitory cleanroom environment where initial batches of product can be manufactured under our ISO13485 QMS for use in preliminary trials, design validation/verification and showcasing events.
All of the above medical device R&D is supported by our internal team of project engineers who bring years of experience with them in medical device manufacturing and assembly methods.
Transfer to Manufacturing
Once your product and processes have been fully developed, you will be ready to quickly transfer the process into our manufacturing facility. Safe in the knowledge that there will be no time or cost hurdles for you to overcome to manufacture your product.
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.
Learn more about what we do by watching our corporate video.
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