Medical Device Regulation & Validation at Europlaz

Regulatory and validation services for the medical industry.

 

Trusted Medical Device Validation and Regulation Services

Europlaz offers a complete range of design, tool, process and medical device 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 device validation service gives clients confidence and reassurance that their products are reliable and uniform. We are equipped with advanced facilities such as cleanrooms, state-of-the-art  , Ethylene Oxide (EO), Gamma, and Auto Clave sterilisation. These services along with our medical device regulation and validation allow you to design and create medical products in safe, clean, and controllable environments.

 

Process of Validation

The medical device validation and regulation process consists of several stages and is tailored to your needs. From various validation protocols (DQ, IQ, OQ, 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.

Our medical device validation processes includes:

  • 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 regulation and validation services please contact us using the booking calendar below or call us now.

Medical Device Validation

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.

Learn more about what we do by watching our corporate video.

Why not book in a telephone meeting with us to learn more about our service offerings?  Use the meeting scheduler below and select a convenient date and time.

Alternatively you can contact us by telephone or email.

 

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Contact Us

To begin discussions about a specific project please complete the form below and we will be back in contact. Alternatively, you can book a telephone call with us using our online Meeting Scheduler. If you are interested in one of our vacancies, please apply through the Careers Page.

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