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    Innovate with confidence. Stay compliant without compromise.

    The pressure to deliver high-quality, compliant medical devices faster than ever is real. Scilife helps QA and product teams align with global standards while staying focused on what really matters: patient safety and innovation.

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    Hand holding a box with a medical cross, symbolizing innovation and growth in the compliant medical device industry | Scilife

    Trusted by leading quality-focused organizations in the medical devices industry

    • 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

    Compliance complexity is holding back innovation

    Whether you're preparing for CE marking, FDA clearance, or MDR compliance, the demands on your quality and product teams are rising.

    But many still rely on spreadsheets, disconnected tools, or paper-heavy systems—causing slowdowns, errors, and last-minute audit stress.


    It’s time for a smarter, more connected approach with a QMS software for medical devices. 

    Illustration showing a shield with a checkmark, representing compliance | Scilife

    The challenge: why great medical devices never reach the market

    Many medtech teams are laser-focused on building the perfect product—sleek prototypes, groundbreaking technology, elegant user interfaces.

    But even the most brilliant design can stall if compliance is left as an afterthought.

    Regulatory standards like ISO 13485 or FDA 21 CFR Part 820 weren’t built in from the start.

    The design history file lacks traceability.

    Quality documentation was never fully planned.

    Audits reveal gaps just as you’re preparing to launch.

    Suddenly, your ‘ready-to-launch’ product needs remediation. Timelines slip by months. Costs spike. Market access is delayed—or lost altogether.

    The root problem: compliance isn’t built in

    In fast-paced product environments, it’s natural to prioritize progress: prototypes, features, clinical feedback.

    But quality and compliance are often postponed because they feel complex, unfamiliar, and hard to integrate without slowing things down.

    Quality is seen as something to ‘add later’, once the design is done.

    Regulatory standards feel like checklists, not part of daily decisions.

    Teams move quickly, but documentation doesn’t always keep up.

    The result? Gaps surface when it matters most—during audits, validations, or certification reviews.

    The solution isn’t to slow down. It’s to build smarter—with compliance as a part of the process, not a separate one.

    How our QMS software for medical devices helps quality

    For QA teams: compliance from day one

    Our Smart QMS software helps QA teams embed ISO 13485 and FDA 21 CFR Part 820 compliance into daily workflows so you’re always inspection-ready, and never playing catch-up.

    - Build traceability across user needs, design inputs, and validations.

    - Track progress and approvals with audit-ready signatures.

    - Eliminate last-minute surprises and documentation gaps.

    Learn more
    Screenshot showing about the design control documentation workflow | Scilife

    How our QMS software for medical devices helps device production

    For development teams: structure that accelerates, not one that slows down

    Scilife supports fast-paced development teams by simplifying how they document and manage design controls, making compliance less manual and more connected.

    - Connect inputs, changes, and approvals in one place.

    - Visualize design control flow and identify gaps early.

    - Reduce costly rework and build confidently toward certification.

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

    Real voices, real results

    • “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
      Daniele Scalco
      Quality Assurance and Regulatory Affairs Manager
    • “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
      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
      Annemarie Booijenga
      QA Lead at Reperio

    Results for medical device innovators

    Scilife 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%

    Switch that turns quality into your brightest asset | Scilife

    Ready to achieve compliance and accelerate innovation?

    Book a demo