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  • Europlaz - Medical device development- medical device manufacturing UK
    material and production experience is invaluable in turning conceptual ideas into products which are functional aesthetically pleasing and efficient to manufacture We know manufacturing so we know how to design for manufacture 3D CAD Device design Material development and selection Biocompatibility studies Prototyping Tool design and build management Manufacturing process industrialization realization and validation By involving Europlaz at an early design stage our experience can help to achieve cost effective

    Original URL path: http://www.europlaz.co.uk/medical-device-development (2016-02-12)
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  • Europlaz - Quality control
    member of the Europlaz team is expected to adhere to the quality management system and to go above and beyond for our customers and the team The Europlaz Quality System means Consistently providing product that meets or exceeds Customer and Business requirements and continually improving the effectiveness of its business processes quality management system QMS 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 organization Developing an appropriate and increasingly skilled and motivated workforce through a training plan linked to the Business Plan The Company is committed to meeting these needs and expectations through an appropriate and relevant QMS based on the principles of ISO9001 2008 ISO13485 2003 CMDCAS ISO13485 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 Executive Management will regularly and systematically review Company strategic objectives and operations to ensure compliance with the QMS to confirm its on going suitability and effectiveness and to review the achievement of its objectives The company will communicate its quality policy and objectives

    Original URL path: http://www.europlaz.co.uk/quality-control (2016-02-12)
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  • Europlaz - Case studies
    products and are proud of all the work we do Most of our work is confidential but please read the case studies to find out about a small cross section of our work Europlaz has extensive knowledge and experience in providing development and manufacturing technologies for the medical device diagnostic pharmaceutical and healthcare industries Medical device development Markets Prototyping Validation Project Management Tooling Manufacturing services Cleanroom Manufacturing Assembly Technical Injection

    Original URL path: http://www.europlaz.co.uk/case-studies (2016-02-12)
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  • Europlaz - Products
    devices medical components and disposable products Please contact us for more information info europlaz co uk Ask for Katy on 44 1621773471 All devices are manufactured in the UK by Europlaz Technologies and a stock holding is available in most cases Medical device development Markets Prototyping Validation Project Management Tooling Manufacturing services Cleanroom Manufacturing Assembly Technical Injection Moulding Packaging Labelling Sterilisation Additional Services Quality control Certificates Validation Cleanroom Quality Control

    Original URL path: http://www.europlaz.co.uk/products (2016-02-12)
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  • Europlaz - Technical Injection Moulding
    components Two shot moulding Insert over moulding Injection moulding facilities 25 injection moulding machines 10 Tonne to 300 tonne 17 housed within class 7 cleanrooms 4 All electric injection moulding machines Injection moulded medical products made on this site since 1970 Largest injection moulding machine in a cleanroom in Europe Machines Sumitomo all electric 35T 100T Krauss Maffei 50T 300T Battenfeld 50T 150T Sandretto 300T Medical device development Markets Prototyping

    Original URL path: http://www.europlaz.co.uk/manufacturing-services/technical-injection-moulding (2016-02-12)
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  • Europlaz - Certificates
    so have issued temporary extensions to our certification This situation will be resolved before September 2015 The Key Elements of ISO9001 2008 ISO13485 2003 are Establish document implement maintain continually improve Identify processes determine sequence interaction Determine control method to ensure effectiveness Ensure supporting resources information are available Measure monitor to achieve planned results and maintain continually improve them To prove we are achieving the required standards we maintain strict quality records these include Supplier Approval performance Records Evidence we have reviewed and monitor our Suppliers to establish and maintain a quality and consistent supply of product materials Inspection Records for demonstrating supplied product materials and outputs from the manufacturing processes meet the specified criteria Training records for demonstrating staff have been trained and are approved as being competent Internal Audit reports non conformity Reports evidence our quality System has been reviewed and any issues identified have been registered and addressed Management Review meeting minutes Evidence senior Management have reviewed the performance of the quality system and have agreed actions for on going continuous improvement Medical device development Markets Prototyping Validation Project Management Tooling Manufacturing services Cleanroom Manufacturing Assembly Technical Injection Moulding Packaging Labelling Sterilisation Additional Services Quality control Certificates

    Original URL path: http://www.europlaz.co.uk/quality-control/certificates (2016-02-12)
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  • Europlaz medical device manufacturing in a cleanroom
    ft Cleanrooms certified to ISO 14644 for airborne particulate 22 injection moulding machines from 10 to 300 Tonne Cleanrooms are specifically designed for processing class 1 and class 11 medical devices equipment and pharmaceutical products Routine air pressure micro organism and airborne particulate monitoring ensure standards are maintained at all times On offer within cleanroom facilities are complete assembly injection moulding and packaging solutions Including High cavitation fast cycle Over moulding Optical moulding Thermal moulding Manual semi automatic and fully automatic assembly Ultrasonic welding Hot Plate welding Hot wire welding Adhesive UV bonding Multi colour pad printing Ultrasonic cleaning Aseptic Filling CE Marking Blister packaging Pouch sealing roller and bar Label production including custom bar codes Packaging validation Quality control is of the highest standard at Europlaz all manufacture is compliant with ISO 13485 2003 and BS EN ISO 9001 2008 Registered FDA Equipment Manufacturing Establishment Reg No 3004180226 Europlaz is able to tailor solutions dependent on your specific requirements Please contact us to discuss your requirements or if you have any questions Medical device development Markets Prototyping Validation Project Management Tooling Manufacturing services Cleanroom Manufacturing Assembly Technical Injection Moulding Packaging Labelling Sterilisation Additional Services Quality control Certificates Validation Cleanroom

    Original URL path: http://www.europlaz.co.uk/manufacturing-services/cleanroom-manufacture (2016-02-12)
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  • Europlaz Complex Assembly - Medical Device Assembly
    approved medical devices Multi component multi material assembly Manual and automated services High and low volume assembly Dedicated customer production cells Flexible batch lot sizes ideal for product start ups Typical processes include Ultra sonic welding Hot plate welding Aseptic liquid filling Laser cutting Multi solvent bonding UV curing Hot wire welding Testing To prevent product contamination Europlaz follows strict rules and procedures meeting specified air flow rates pressurization temperature

    Original URL path: http://www.europlaz.co.uk/manufacturing-services/complex-assembly (2016-02-12)
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web-archive-uk.com, 2017-12-17