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    Meet ISO 13485 and 21 CFR part 820 requirements and accelerate time to market

    Align quality assurance and product development workflows, ensuring complete traceability with Scilife smart QMS for Medical Devices.
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    All your medical device design controls centralized in one space

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    Challenge

     

    Medical device companies often manage quality with multiple, unconnected systems, leading to a fragmented approach.

    These non-scalable systems make it hard to keep development and quality teams aligned and adapt to new regulations and market demands as companies grow.

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    Solution

     

    Accelerate product development and ensure seamless design control with Scilife Smart QMS for medical devices.

    Gain full oversight with an automated traceability matrix, version control, and compliant electronic signatures—ensuring regulatory compliance while streamlining workflows.

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    Complete toolset

    Manage your medical device by leveraging other Scilife tools like Documents, Records, Events, CAPAs, and Change Control.

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    Streamlined compliance

    Ensure ISO 13485:2016 and FDA 21 CFR 820 compliance with proper approvals using 21 CFR Part 11 electronic signatures.
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    Automated traceability matrix

    Spot gaps in requirements effortlessly with an auto-generated audit trail.

    Simplified design and development process:


    • Don’t let design controls documenting slow you down; trace your design controls effortlessly and find gaps in the traceability matrix with just one click.
    • Reduce time-to-market with a simplified approval cascade. 
    Screenshot that shows the approval cascade of a design control software for medical devices | Scilife

    Clear and comprehensive traceability at every stage:


    • Link design controls with user needs, assess the impact of every change on validation, and easily track testing and verification.
    • Provide detailed project oversight to all involved teams and boost visibility and collaboration. 
    Screenshot that shows how a design control software for medical devices ensures full traceability | Scilife

    Improved version control:


    • Analyze project changes at first glance comparing prior versions of the product with the current one.
    • Assess the evolution of the project and provide valuable insights during audits. 
    Screenshot that shows the version comparison tool of a design control software for medical devices | Scilife

    Exciting updates ahead!

    Our latest Design and Development solution is set to launch soon!"

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    Turn quality into your brightest asset with Scilife

    When we embrace quality, brilliant things happen!
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    EMEA Office
    Louizalaan 489
    1050 Brussels
    Belgium

    US Office
    Scilife Inc.
    228 E 45th St. RM 9E
    New York, NY 10017

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      EMEA Office
      Louizalaan 489
      1050 Brussels
      Belgium

      US Office
      Scilife Inc.
      228 E 45th St. RM 9E
      New York, NY 10017

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