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  • SAI Global's platforms are designed to connect and empower your Medical Device company with the regulations and best-practice information you need, whenever you need it to boost productivity, ensure consistency, remain compliant and gain a competitive edge in a challenging regulatory and supply chain space.

    Solution overview

    • Comprehensive and reliable Standards and regulatory management specifically designed with Medical Device Manufacturers in mind.
    • Online subscription-based software as a service solution enabling users in functions such as: Legal and Regulatory Affairs, Quality Audit, Test Engineering, Product Development, R & D to access, group, manage and add notes to over a million Standards and company documents, all in one place, giving each individual one frame of reference.
    • Create secure, flexible and cost-effective collections and project areas based on the product under development at any given time.

    Benefits for your organisation

    Cross reference company documentation with Standards

    A well-managed Standards library can make the difference between a positive and negative outcome when managing risk, which is integral to anyone working within the Medical Devices space

    Streamline Standards management by linking internal documents, policies, drawings, images and guidelines alongside your Standards, establishing a go-to in-house knowledge base which can be developed for each user group and/or for each product being developed.

    In addition, you can share Standards across your organisation and enable business teams to access the latest information from a central online hub.

    Create customised Standards collections for your industry

    Configurable features make it easy to create a collection of Standards relevant to your Medical Devices sub-sector or area of product development focus. You can quickly locate the Standards you use most and create a core reference point for all staff.  

    Users can set up personalised project areas to broadcast best practices by adding notes to documents, linking to additional content and archiving irrelevant content. 

    It's also very easy to add to your collection when needed using 'unlock and add' capabilities.  

    Stay on top of changing Standards

    Monitor ever-changing Standards updates and revisions specific to the product that you are working on. With timely email notifications of relevant changes, you can easily identify the most current Standards and eliminate compliance gaps for good.  

    Updated Standards versions are added to your subscription automatically, giving your team advance notice to proactively plan and update business processes and documentation in one place.

    Create secure, flexible and cost-effective collections based on business need.

    • Standards Management
      in Practice

    • Key Publishers for
      Medical Device Industry

    • EU MDR 2021 and Beyond:

    • Stay on top of Regulatory Obligations

    • Find out more

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