Medical Device Assembly & Packaging
Medical device assembly within seven ISO Class 7 cleanrooms.
Trusted Medical Device Assembly Services
Europlaz have designed a complete medical device assembly chain designed to withstand the rigours of modern medical requirements and safety standards. Our systems include:
- Seven ISO Class 7 cleanrooms covering over 9,500 sq ft
- Cleanrooms certified to ISO 14644 for airborne particulate
- 24 injection moulding machines from 10 to 300 Tonne
With these advanced spaces we are capable of designing, prototyping, and manufacturing every part of your medical device assembly line. Whether you need class I or class II medical devices, medical equipment or pharmaceutical products produced, Europlaz is on hand to provide reliable medical device assembly and packaging. To help maintain these high standards we carry out routine air pressure, micro-organism and airborne particulate monitoring.
Find out more about why customers choose Europlaz here.
Medical Device Assembly Packaging Services
As a medical device assembly company, we understand packaging medical products in a safe and clean environment is just as important as production. Our high cavitation, fast cycle injection moulding production services are supported by a range of medical device assembly and packaging services including;
Manual, semi-automatic and fully Automatic medical device assembly
Hot Plate welding
Adhesive & UV bonding
Multi-colour pad printing
Pouch sealing (roller and bar)
Label production (including custom bar codes)
Cleanroom Quality Control for Medical Device Assembly
Quality control is of the highest standard at Europlaz; all medical device assembly is compliant with ISO13485 and BS EN ISO 9001-2008.
We are a registered FDA Equipment Manufacturing Establishment (Reg. No. 3004180226)
Europlaz is able to tailor solutions dependent on your specific requirements.
In House Automation
Europlaz can design, source and commission automation equipment to complete critical medical device assembly tasks and verify the completion of that task.
Where there are production efficiencies to be gained, we will work with you to drive down costs and increase output.
Typical equipment used includes integrated vision systems, SCARA, 6-axis and cartesian robots. We can provide test stations ranging from a simple process test to full device testing with a verifying data record of each test.
Our automation capabilities include:
- Expert knowledge of high-speed automation
- Established automation supply chain
- In-house designing, machining, programming and system construction
- Development of custom assembly stations and custom test stations
- 100% device verification systems
- Lab-based “Proof of Concept” activities
- Scale-up automation from development through full production
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.