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    Smart Quality Management Software according to ISO 13485 and 21 CFR part 820

    Manage the whole Medical Device design control and product development process according to strict compliance regulations and bring your medical device to market faster.

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    Medical Device seeding control and product development software | Scilife

    Trusted by leading quality-focused organizations in the life sciences

    • Logo of Amnovis, a Scilife QMS customer | Scilife
    • Logo of Caristo, a Scilife QMS customer | Scilife
    • Logo of Midiagnostic, a Scilife QMS customer | Scilife
    • Logo of Novosanis, a Scilife QMS customer | Scilife
    • Logo of Biocartis, a Scilife QMS customer | Scilife
    • Logo of Olfactomics, a Scilife QMS customer | Scilife
    • Logo of Shoebox, a Scilife QMS customer | Scilife

    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.

    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.
    Creative illustration featuring a medical device box sprouting flowers.This artwork highlights how design control in the medical device development process can improve lives and foster innovation in healthcare | 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.
    Screenshot showing details about the design control workflow and medical device product development process | Scilife

    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.

    Screenshot showing details about the traceability matrix and medical device product development process | Scilife

    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.
    Screenshot showing details about the version comparison tool and medical device product development process | Scilife
    Upcoming release!
    New features on the horizon
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    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. 

     
    Symbol of more | Scilife

    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 latest Design and Development solution is set to launch soon!
    Image of a 'Coming Soon' clock representing upcoming updates | 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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