Regulatory and Validation Services for the Medical Industry
Improve your medical device design, tooling, and production with our meticulous validation service.
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.
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.
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.