AI-Powered Compliance Packages for MedTech & SaMD Startups

🔹 Exclusive AI-powered compliance solutions + AI-driven auditing

🔹 Faster, smarter, and cost-effective regulatory success –Shorter time-to-market

🔹 End-to-end expert guidance – From startup to global market leader


📍 Meet us at WMC Barcelona!

📅 March 3-6 | Hall 8.0, Stand 8.0B17.6

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STARTEr COMPLIANCE KIT - OFFER GROWTH COMPLIANCE KIT - OFFER SCALE-UP&POST-MARKET kiT -OFFER

STARTER COMPLIANCE KIT

For startups in the early development phase that need to build a regulatory foundation without slowing innovation.
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    • Software companies moving into SaMD
    • MedTech startups building their first device
    • Teams without QMS or regulatory expertise
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    • Regulatory Roadmap Definition
    • AI-Powered eQMS Setup
    • Design Controls & Risk Management Implementation (ISO 14971)
    • Preliminary Clinical & Usability Compliance Setup (IEC 62304 for SaMD, IEC 62366 for usability)
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    • Faster eQMS implementation Set-up– in weeks not months
    • Regulatory alignment from the start – no rework later
    • Lower early-stage compliance costs
    • Get investors onboard by showing a solid strategy and execution

GROWTH ACCELERATOR kit

For startups preparing for regulatory submission & market entry, needing a fast-track approval strategy.
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    • Startups finalizing their Medical Device or SaMD for submission

    • Companies requiring regulatory filing (MDR, IVDR, 510(k), De Novo, PMA, etc.)

    • Startups undergoing clinical evaluation or validation testing
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    • AI-Driven Documentation Automation

    • Pre-Submission Consultation (FDA Q-Sub, Notified Body Early Interaction)

    • Pre-Audit Readiness Check– Detect & correct compliance gaps before official review

    • Clinical Evaluation & Performance Studies Support

    • Full implementation of eQMS and ISO13485 certification support

    • Regulatory Submission Assistance

    • Regulatory & Notified Body Review Support

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    • Shortened time-to-market with automated compliance processes

    • Reduced audit findings & delays

    • Lower submission costs vs. traditional regulatory consultants

    • Be ready to scale

SCALE-UP & POST-MARKET COMPLIANCE PACKAGE

For MedTech companies looking to maintain compliance, expand globally, and scale operations.
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    • Companies with existing market approval (CE Mark, FDA, etc.)

    • Startups preparing for MDR/IVDR/FDA audits & post-market compliance

    • Companies expanding to new markets
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    • Digitalization of QMS into an eQMS of your choice

    • AI-Powered Continuous Auditing– Always audit-ready, automatic compliance monitoring
    • Post-Market Surveillance

    • Regulatory Updates & Ongoing Compliance Support

    • Expansion Strategy for New Market Approvals

    • Risk & Quality System Optimization
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    • Eliminate last-minute audit stress with AI-powered monitoring

    • Minimize compliance risks & avoid regulatory penalties

    • Faster & smoother expansion into new markets