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    Consolidate data, strengthen design controls, and achieve compliance

    Document your medical device product development in a validated medical device QMS software. Maintain robust design controls and achieve ISO 13485 & FDA 21 CFR 820 compliance without manual complexity.

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    QMS software for medical devices product | Scilife

    Stay compliant with confidence

    Our medical device quality management software is built to meet ISO 13485 and FDA 21 CFR Part 820 requirements, helping you simplify audits, reduce risk, and stay inspection-ready.

    Streamline quality processes

    Automate your most critical quality workflows with a compliant and structured QMS software for medical devices that's equipped with document control, training, and event management.

    Control design and compliance

    Manage design documentation with clarity using structured workflows, built-in oversight, and traceable records, all backed by 21 CFR Part 11-compliant audit trails and e-signatures.
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    Trusted medical device QMS software by leading medical device organizations
    • Orasure logo, Scilife customer | Scilife
    • Biocartis logo, Scilife customer | Scilife
    • Shoebox logo, Scilife customer | Scilife
    • Amnovis logo, Scilife customer | Scilife
    • Caristo logo, Scilife customer | Scilife
    • miDiagnostic logo, Scilife customer | Scilife

    Complete medical device quality management software

    Explore our comprehensive medical device QMS feature set to streamline compliance and design control documentation:

    Document control solution for medical devices | Scilife

    Document control

    Take control of every document, from creation to approval, with automation, audit trails, and permission settings tailored for compliance.
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    Design and develop solution for medical devices | Scilife

    Design and development tool

    Streamline your design process with intuitive workflows, a powerful traceability matrix, and a version comparison tool.
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    Training and competence solution for medical devices | Scilife

    Training and competence

    Ensure your team is always audit ready with role-based training linked to document updates and compliance requirements.
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    Quality events and CAPAs solution for medical devices | Scilife

    Quality events and CAPAs

    Capture deviations, complaints and events in real-time, ensuring thorough documentation and corrective actions.
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    Change control and supplier management solution for medical devices | Scilife

    Change control and supplier management

    Manage change requests and supplier qualifications from one secure platform, ensuring ongoing product safety and reliability.
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    Results for medical device innovators

    Our medical device QMS software gives your team the tools to innovate confidently, cut costs, and stay audit-ready.

    Reduce time-to-market by up to
    35%

    Lower compliance costs by up to
    50%

    QMS software for medical devicesthat delivers—just ask our customers

    • “Scilife has made our life easier in so many ways. One of the things I like the most is how it integrates different processes. It gives a bigger picture of everything and allows us to keep track of deviations and see opportunities for improvement.”
      Daniele Scalco Vasconcelos, Quality Assurance and Regulatory Manager at Idevax | Scilife
      Daniele Scalco
      Quality Assurance and Regulatory Affairs Manager at Idevax
    • “Amanda is our QA department. She's able to kind of handle this entire volume of work as we grow and as we move because she has Scilife as a tool to rely on.”
      Sarah Mersereau, Quality and Regulatory Manager at SHOEBOX | Scilife
      Sarah Mersereau
      Quality and Regulatory Manager at SHOEBOX
    • “Scilife really helps you to be compliant and it saves you a lot of money and time that you can then spend on other things.”
      Annemarie Booijenga, QA Lead at Reperio | Scilife
      Annemarie Booijenga
      QA Lead at Reperio

    Medical device quality management software packages offering

    Explore flexible medical device QMS packages built for device manufacturers and their QA teams.

    Free

    Unlimited free access to start your Smart Quality journey

    Start for free
    Start with:
    • Unlimited users
    • Unlimited electronic signatures
    • Scilife Academy access
    • KPIs
    • Up to 20 documents
    • Up to 5 trainings

    Essential

    Let no compliance slip through the cracks

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    Everything in 'Free' included, plus:
    • Design and Development
    • Unlimited documents
    • Unlimited trainings
    • Competences
    • Records
    Most popular

    Core

    Everything you need to manage your quality system.

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    Everything in 'Essential' included, plus:
    • CAPAs
    • Change control
    • Quality events (deviations, non-conformities, complaints, event management)

    Core +

    The comprehensive solution to manage quality smartly.

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    Everything in 'Core' included, plus:
    • Audits
    • Supplier management
    • Risk assessment
    • Equipment

    See all Pricing

    SCILIFE - Switch

    Ready to simplify compliance and streamline design control for your medical devices?

    Book a demo