Home 9 Service 9 ISO 7 Cleanroom Manufacturing

ISO 7 Cleanroom Manufacturing

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:

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
medical device assembly

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;

Over moulding
Optical moulding
Thermal moulding
Manual, semi-automatic and fully Automatic medical device assembly
Ultrasonic welding
Hot Plate welding
Hot-wire welding
Adhesive & UV bonding
Multi-colour pad printing
Ultrasonic cleaning
Aseptic Filling
Blister packaging
Pouch sealing (roller and bar)
Label production (including custom bar codes)
Packaging validation

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.

medical device assembly
medical device assembly

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

Manufacturing Excellence for Healthcare Innovation.

Helping OEMs and Inventors to scale their businesses by partnering with a flexible medical device contract manufacturer.

Want to find out more?

About Europlaz

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.

For further information you can watch our Corporate Video to the right-hand side, view our Corporate Brochure or Contact Us.

Book a Meeting

To learn more about Europlaz’s services and the different medical devices we have helped develop, book a telephone meeting with one of the team.

To do this simply use the Schedule Meeting button below.

Alternatively you can contact us by telephone or email.

01621 773471

All Other Services

Medical Device 3PL

Assisting with the entire logistic process from manufacturing, storage, picking to shipping.

Renting R&D Space

For clients who are undertaking advanced stage R&D work and require our facilities and services.

Sterilisation

Understand our Ethylene Oxide, Gamma and Auto Clave sterilisation process.

Risk Management

Providing you with a risk management plan to ensure all risks are identified, managed and mitigated.

Latest News

Read more about our news on medical device manufacturing and development in the UK

How Outsourcing to Medical Contract Manufacturers Has Evolved

How Outsourcing to Medical Contract Manufacturers Has Evolved

Outsourcing to medical contract manufacturers (MCMs) has become an integral part of the healthcare industry, significantly shaping the way medical devices and products are developed, produced, and brought to market. The evolution of this outsourcing practice is marked...

Read more

Design Considerations for Injection Moulding

Design Considerations for Injection Moulding

Injection moulding is one of the most widely used manufacturing processes for creating plastic parts and products. Its versatility allows for the production of complex shapes with high precision, making it ideal for mass production. However, designing for injection...

Read more