ISO:13485:2016 Medical Device Quality Assurance

Consistent Quality and Supply with Leading Medical Device quality assurance (QA).

Ensures your product meets industry requirements.

ISO Approved Medical Device Quality Assurance and Management System

To view our ISO 13485:2016 certificate click here.

Europlaz understands that each customer is unique, but the need for a consistent supply of a quality product is universal. The importance of medical quality assurance processes to a medical device manufacturer, and to medical staff and patients, cannot be understated. Partnering with a contract manufacturer with comprehensive quality assurance protocols and systems ensures that the highest standards of quality are always maintained and that your brand and reputation are fully protected.

We are deeply committed to medical device quality assurance (QA) processes and guide our practices with a focus on maintaining and improving our practices to ensure customers understand the advantages and need for medical device QA.

Every member of the Europlaz team is expected to adhere to the quality management system and to go above and beyond for our customers.

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Exceeding Medical Device QA Expectations

The Europlaz Quality Management System (QMS) is an internal system that allows us to maintain high medical device quality assurance standards and consistently provide a product that meets or exceeds customer and business requirements, such as ISO:13485:2016 and the FDA.

The company is committed to meeting these needs and expectations through an appropriate and relevant QMS, based on the principles of ISO13485:2016, the European Medical Device Directive 93/42/EEC, the FDA 21 CFR part 820 Quality System Regulations for Medical devices, and the establishment and delivery of related quality objectives.

This is done by providing enhanced customer satisfaction and business performance through the identification, development, implementation and review of a series of quality objectives, for application at all levels of the organisation. Our team reinforce this practice further by developing an appropriate and increasingly skilled and motivated workforce through a training plan linked to the Business Plan.

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Regular Revisions to Medical Device Quality Assurance Procedures

Our management team regularly and systematically review the company’s strategic objectives and operations to ensure compliance with the QMS, and to confirm the ongoing suitability and advantages of medical device QA.

Europlaz communicates its quality policy and objectives to all levels of the organisation and promotes understanding, involvement and commitment amongst all employees.

Our quality assurance processes are beneficial for a wide range of clients and industries across the globe with our practices recognised by both ISO and FDA governing bodies.

For the European market – manufacturers must operate and products must be manufactured according to the international standards ISO 13485: 2016. In doing so, ISO certifications reduce the chance of surprises or failures at all stages of the process – upholding patient safety and manufacturers’ reputations.

For the US market – the manufacturer must also be registered with the Food and Drug Administration (FDA), a federal agency of the United States Department of Health and Human Services, and follow the stipulations set out in the 21 CFR 820 regulation that covers quality systems for medical devices.

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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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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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