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Medical Device Validation Services

Trusted Medical Device Validation and Verification Services

Europlaz offers a complete range of design, tool, process and equipment validation options to meet the various needs and expectations of its customers. Validation is the process of ensuring your medical device, product, or part is safe and functions correctly for each and every patient.

Our medical validation services give clients confidence and reassurance that their products are reliable and uniform. We cover all angles, including verifying all of our medical validation systems, to offer a service that meets strict requirements.

Once organised and signed off, we get to work with advanced facilities such as ISO class 7 cleanrooms, state-of-the-art injection moulding equipment, Ethylene Oxide (EO), Gamma, and Auto Clave sterilisation. These validation services along with our medical device design, allow you to design and create medical products in safe, clean and controllable environments.


medical device validation
Medical Device Validation

Process of Validation

The medical device validation process consists of several stages and is tailored to your needs. From various validation protocols (DQ, IQ, OQ and PQ) to medical equipment installation qualifications, product performance qualifications and more; Europlaz is perfectly placed to help you achieve accreditations and ensure reliable medical performance.

We include validation as part of the complete Europlaz service to ensure that your project runs smoothly. These medical validation services include:

  • Master Validation Plans
  • Validation Protocols (DQ, IQ, OQ, PQ)
  • Process Failure Mode and Effects Analysis
  • Installation qualification
  • Design of experiments
  • Operational qualification
  • Performance qualification
  • Product characteristics evaluation
  • Gauge R&R/measurement system analysis

For more information on our medical device validation or how we can assist with design and development please contact us today using the booking calendar below or call us now.

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 left-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.


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

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