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Why AMD
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  • AMD Packaging with Tyvek
  • AMD Sterilization Reel & Pouch
  • AMD Chemical Indicators & Tapes
  • AMD Medical Disposable
  • AMD Heat Sealer
    • Hopeway AMD About Hopeway AMD
  • Hopeway AMD Group: Trusted Designer and Manufacturer of Sterilization Packaging and Control Products
    • Founded in 2004, Hopeway AMD Group is a trusted leader in the design and manufacturing of sterilization packaging and control products. With over 20 years of industry expertise, we have built an unrivaled foundation of knowledge and experience. Our mission is to provide the medical device, healthcare, and pharmaceutical industries with high-quality sterilization packaging solutions that ensure safety, compliance, and reliability.

  • Certified Sterilization Packaging Manufacturer – Compliance with EN ISO 13485:2016
    • Hopeway AMD Group is a certified manufacturer under the internationally recognized EN ISO 13485:2016 standard, ensuring that all our sterilization packaging and control products comply with stringent regulatory requirements. Our manufacturing processes, including advanced printing, coating systems, and cutting-edge finishing machinery, are conducted in controlled cleanroom environments. Every production step follows validated processes to ensure the highest product standards. These processes include:

    • - Raw Material Control & Testing: Rigorous inspection of materials before warehouse entry.
    • - Product Validation: Thorough validation checks before production begins.
    • - In-Process Inspections: Continuous monitoring and testing during production.
    • - Material Traceability: Full traceability of all materials used throughout production.
  • Stringent Quality Control for Optimal Product Performance
    • We operate in a strictly controlled production environment with a comprehensive testing process. Our highly trained quality control personnel, supported by detailed data analytics, ensure our products meet various physical standards such as particle content, microbial limits, leakage resistance, tensile strength, blasting strength, and other regulatory requirements for bacterial packaging. For specific packaging needs, additional tests are performed based on the material’s nature, intended use, and applicable regulatory standards.

  • Why Choose Hopeway AMD Group for Your Sterilization Packaging Needs?
    • As a Hopeway AMD customer, you can trust that our sterilization packaging solutions meet the highest standards of quality, safety, and compliance, ensuring your products are always fully protected.

    Hopeway AMD Group Compliance with Key International Standards:

    • TÜV SÜD certified EN ISO13485:2016, Medical device – Quality Management System

      MDR(EU) 2017/745
      EN 868
      EN ISO 11607
      EN ISO 11140
    Hopeway AMD Mission & Vision & Value
    At Hopeway AMD, sterilization package & control is much more than a product or a solution:

    It is the journey gathering respects for everyone, innovations to every prospect and trusts in every step, that Hopeway AMD preserves to pursuit.

    It is the combination of strict standards, sustainable designs and comprehensive commitment that Hopeway AMD dedicates to improve.

    • Hopeway AMD B.V.
    • Hopeway AMD B.V.
    • Hopeway AMD B.V.
    • Hopeway AMD B.V.
    Hopeway AMD B.V.

    Hopeway AMD

    High Standard Testing

    We have EN ISO 13485:2016 medical device quality management system certified production line and TÜV SÜD certified. During the production process, we execute heat seal strength, peel strength, and leakage tests to ensure that the sampling results of each batch of products comply with EN 868 and EN ISO 11607 standards.

    Clean Room Facilities
    ISO Class 8 Cleanroom (Class 100,000)
    ISO Class 7 Cleanroom (Class 10,000)
    ISO Class 5 Cleanroom (Class 100)

    • Hopeway AMD B.V.
    • Hopeway AMD B.V.
    • Hopeway AMD B.V.

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