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    Hand drawn illustration of a box and a ruler to represent Design & Development solution for Medical Devices by Scilife eQMS | Scilife

    Design and Development according to ISO 13485 and 21 CFR 820

    Manage the whole Design and Development process according to strict compliance regulations and bring your medical device to market faster.
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    Are your design and development processes slowing you down? 

    Bringing a medical device to market is a long and challenging process. There are multiple stages of design and development to navigate, as well as validation, before obtaining regulatory approval. And when human errors occur or documents go missing, this causes significant delays. 

    Streamline the entire process and reduce time to market by up to 50%

    Scilife Design and Development sets you up with an automated traceability matrix that connects thousands of items in one click. We make it easy to link elements, maintain version control, and use compliant electronic signature.
    Design and Development solution for Medical Devices by Scilife's eQMS | Scilife

    Get faster to market with
    one-click solutions

    Streamline whole process

    Enhance workflow clarity and streamline your design and development process from inception to launch so that you can accelerate to market. Benefit from an intuitive visualization of the entire approval cascade for each process workflow. If you are a medical device company and need fast, efficient regulatory lifecycle management, the Scilife Design and Development solution is for you. 

    Image that shows the approval cascade, part of the Design and Development Solution by Scilife eQMS
    Image that shows the traceability matrix, part of the Design and Development Solution by Scilife eQMS


    Ensure full traceability

    Effortlessly navigate your design and development process.
    Our traceability matrix allows you to connect design inputs with user needs, evaluate the impact of changes on validation, and track testing and verification steps with ease. Quickly filter and address unlinked items and traceability gaps, ensuring comprehensive oversight and streamlined project management.

    Version comparison tool

    Enhance your traceability capabilities with our
    comparison tool. This feature empowers users to further streamline traceability by comparing project changes between prior versions and the current one. Such a tool is invaluable in assessing the evolution and progress of a project, especially during audits.

     

     

     

     

     

     

    Image that shows the comparison tool, part of the Design and Development Solution by Scilife eQMS

    New features on the horizon
    Sneak peek at our upcoming release!

     

    Single-click submissions

    No more hours of manually compiling data and documents. Control all documents in the cycle for foolproof regulatory submissions. With a single click, thousands of documents can be exported and packaged in one file that can be shared with regulatory bodies. 

    Risk assessments
    automatically linked

    With Scilife Design and Development, risk assessments are automatically linked to the process. You will no longer have to manually check that every new version of each document has a corresponding risk assessment as you will be notified if this is the case.

    Our Design and Development
    solution will be released in the first
    quarter of 2024     !