• SAI Global provide Medical Devices companies with key Standards content to assist their journey through the regulatory maze to ensure compliance.

    We offer content from key Publishers creating Standards for the Medical Device industry, including:


    CEN and CENELEC

    Through their more than 20 Technical Committees dedicated to medical equipment, CEN and CENELEC develop European Standards setting safety, quality and performance requirements for medical devices that are put on the European market. A large number of them enable manufacturers to make their medical products compliant with the European legislation in the medical sector, for the ultimate benefit of all European citizens.


    ASTM

    ASTM offers Medical device and implant standards which are instrumental in specifying and evaluating the design and performance requirements of a number of biomedical materials, tools, and equipment. These medical device and implant standards allow material and product manufacturers, medical laboratories, and other concerned institutions to inspect and assess such instruments to ensure proper quality and workmanship.


    ISO

    Safety and quality are paramount in the medical devices industry. Regulatory requirements are increasingly stringent throughout every step of a product's life cycle. Organisations in the industry are expected to demonstrate their quality management processes and ensure best practice in everything they do and this is where ISO standards can help them in achieving this.


    Managing Content


    We can bring the selection of content that you require to you via the power of our SaaS Standards Management Platform.

    i2i provides Regulatory Affairs teams, Quality Assurance Managers, Research and Development professionals and Engineers with:


    • A configurable secure on-line environment for organizing Standards and Technical Documents
    • Links to cross referenced information and equivalences
    • Storage for your internal documents, drawings, photographs and best practice guidelines alongside National and International Standards.
    • 24/7 Full text access to critical international standards
    • Standards automatically updated online
    • Automatic notification when your standards are updated - essential for those ISO or other quality audits
    • Online Viewer for quick access to content and download.
    • Standards Management Platform

    • Standards Management
      in Practice

    • Standards Content for
      Medical Device Customers

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