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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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    • Logo of Scilife customer Biocartis, user of Scilife QMS for Medical Devices | Scilife
    • Logo of Scilife customer Amnovis, user of Scilife QMS for Medical Devices | Scilife
    • Logo of Scilife customer Shoebox, user of Scilife QMS for Medical Devices | Scilife
    • Logo of Scilife customer Novosanis, user of Scilife QMS for Medical Devices | Scilife
    • Logo of Scilife customer Olfactomics, user of Scilife QMS for Medical Devices | Scilife
    • Logo of Scilife customer Caristo, user of Scilife QMS for Medical Devices | Scilife
    • Logo of Scilife customer Midiagnostics, user of Scilife QMS for Medical Devices | Scilife

    All your medical device design controls centralized in one space

    Image that represents the main challenges of not having a design control software for a Medical Device | Scilife

    Challenge

    Medical device companies often manage quality with multiple, unconnected systems, leading to a fragmented approach. The non-scalable nature of these systems makes it difficult to keep development and quality teams aligned.
     
    Moreover, as companies grow, their quality management processes do not grow with them, hampering the ability to quickly adapt to new regulations and market demands.
     
    Image that represents the benefits of implementing a design control software for Medical Device | Scilife

    Solution

    Scilife Smart QMS for Medical Devices streamlines your medical device product development and keeps track of all aspects of the design control process.

    It enhances transparency and collaboration between quality and engineering teams with its audit trail and traceability matrix, version control, automated notifications, and compliant electronic signatures.

    Icon that represents a traceability matrix of a design control software for medical devices | Scilife

    Ensure full traceability

    Connect design controls and track their verification and validation steps for enhanced project oversight.
    Icon that represents how to automate tasks with a design control software for medical devices | Scilife

    Automate documentation tasks

    Guarantee spotless design controls and avoid errors and delays in product development.

    Icon that represents how to improve collaboration with a design control software for medical devices | Scilife

    Drive collaboration

    Align product development and quality teams, link both processes, and get rid of data silos.

    Simplified design and development process:


    • Don’t let design controls documenting slow you down; automate the whole process, connect all items with just one click, and avoid human errors.
    • Reduce time-to-market by up to 50% 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!"

    Illustration that represents Design control software for Medical Devices | Scilife
    Illustration that represents how Scilife smart QMS can help you improve your quality processes

    Turn quality into your brightest asset with Scilife

    When we embrace quality, brilliant things happen!
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