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    Simplify design controls for medical devices and stay effortlessly compliant

    Scilife’s medical device design and development solution streamlines traceability, accelerates audit readiness, and eliminates the rework, delays, and messy workflows that hold QA and product teams back.

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    Medical kit box with cross and growing plants beside a ruler, symbolizing growth and compliance | Scilife
    Trusted product development platform 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

    Medical device product development software to help you stay on top of compliance and reduce time to market

    Scilife medical device design and development sets you up with an automated traceability matrix that connects your design controls in one clear view. We make it easy to keep track of changes, compare versions, and manage approvals with compliance electronic signatures.

    Are your medical device 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, before obtaining regulatory approval. And when human errors occur or documents go missing, this causes significant delays.
    Alarm clock with downward arrows, symbolizing time pressure and delays in development | Scilife

    Get to market faster with an audit-ready medical device product development software

    Medical device product development software built for market launch

    Speed up your journey from design controls to approval with a structured, compliant workflow built for medical device teams.

    • Get full visibility from user needs to validation with structured documentation
    • Navigate every step of the design control process using a clear, visual workflow
    • Benefit from a comprehensive 3-step approval cascade with 21 CFR Part 11 electronic signatures
    • Accelerate to market while ensuring compliance with ISO 13485:2016 and FDA 21 CFR 820
    Screenshot showing details about the design control workflow and medical device product development process | Scilife

    Ensure full traceability in your medical device design and development 

    Maintain oversight and reduce compliance risks with a built-in traceability matrix—no manual effort required.

    • Automatically connect user needs, design inputs, outputs, verifications, and validations
    • Spot and resolve traceability gaps quickly through a visual, filterable matrix
    • Ensure all design elements are properly documented, linked, and ready for inspection
    • Save hours of manual work with real-time traceability.
    Screenshot showing details about the traceability matrix and medical device product development process | Scilife

    Product development platform with a built-in version comparison tool 

    Track and identify what changed—without the audit day scramble.

    • Use the built-in version comparison tool to review changes between versions.
    • Compare at project, phase, or item level for detailed oversight.
    • Support audits and team reviews with a clear record of changes. No need to piece documentation together retroactively.
    • Ensure transparency across your design process, without guesswork.
    Screenshot showing details about the version comparison tool and medical device product development process | Scilife

    FAQs

    What regulations does the Design and Development tool comply with?

    The Design and Development tool helps medical device companies comply with ISO 13485:2016, EU MDR, and FDA 21 CFR 820 requirements.

    What user roles are available in the Design and Development tool?

    • Creator: any Scilife user with Design and Development access. Manages project details and design control items.
    • Responsible person: required role to sign off project phases and items.
    • Reviewer: optional role to approve or send items back to draft.
    • QA: optional role for final approvals.

    How can reviewers and QAs provide feedback?

    They can add remarks when approving or sending items back to draft. These remarks are stored in the audit trail.

    How can I create reports or a DHF in the Design and Development tool?

    You can export traceability matrices, audit trails, and design control lists to Excel or CSV. Use these files to compile your device’s technical documentation, then upload to Scilife Documents for review and e-signature.

    Can I link documents to Design and Development items?

    You can upload the document in Document control and add the hyperlink in the description fields of your projects or design control items.

    How are design reviews handled?

    Design and Development allows you to review and approve individual items, avoiding the need to re-approve everything every time a single requirement is updated.

    How can I manage sub-systems or sub-requirements?

    You can categorize using user need categories or prefixes in item titles.

    How can I detect traceability gaps?

    Use the traceability matrix and filter by unlinked items to find and resolve gaps.

    Does the Design and Development solution help with IEC 62304 compliance?

    Yes, it helps document software lifecycle activities (like requirements, design, coding, verification, and validation). Additional documentation for SDLC and change management can be managed using the Change Control tool in Scilife.

    Scilife switch to making quality brighter | Scilife

    Take control of design control documentation, without the complexity

    Learn how Scilife’s Design and Development tool helps QA and product teams simplify traceability, eliminate rework, and stay audit-ready with confidence.
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