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法規合規

  • Formly helps startups handle EU and US medical device compliance using AI and expert guidance.
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    What is FormlyAI?
    Formly provides a comprehensive solution for startups to achieve medical device certification compliance in the EU and US markets. By leveraging AI technology and a team of experienced regulatory experts, the platform simplifies the documentation process required for ISO 13485 compliance, technical documentation, and change management. Formly ensures that companies can scale according to their needs and stay updated with compliance alerts, automating tedious documentation tasks. Suitable for various device classes, it accelerates the go-to-market process, ensuring that all regulatory standards including MDR 2017/745 and US FDA 21 CFR are met.
    FormlyAI Core Features
    • ISO 13485 compliant QMS
    • AI-driven documentation
    • Change Management
    • Compliance alerts
    • Export capability
    • Data integration
    FormlyAI Pro & Cons

    The Cons

    No open-source availability limits customization or community contributions.
    Lacks public presence of mobile or app store platforms.
    May require organizational buy-in to integrate with existing workflows.
    Detailed info about the extent of AI capabilities is limited on the main site.

    The Pros

    Combines AI efficiency with human regulatory expertise for comprehensive compliance management.
    Supports a wide range of certification standards and medical device types.
    Provides a clear and complete certification roadmap tailored to complex products.
    Enables scaling across multiple devices and international markets.
    Offers predictable and transparent pricing tailored to client needs.
    Automates compliance processes reducing time and resource drain.
    FormlyAI Pricing
    Has free planNo
    Free trial details
    Pricing model
    Is credit card requiredNo
    Has lifetime planNo
    Billing frequency
    For the latest prices, please visit: https://www.formly.ai
  • Smart Audit is an AI agent that conducts automated audits and assessments efficiently.
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    What is Smart Audit?
    Smart Audit harnesses advanced AI algorithms to carry out comprehensive audits, analyzing data to ensure compliance with industry standards. It streamlines the audit process, offering users detailed insights and recommendations for improvements. By integrating with existing systems, Smart Audit provides seamless monitoring and reporting, facilitating proactive decision-making and risk management.
  • Simplify compliance and build trust with Termio's AI-powered solutions.
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    What is Termio?
    Termio is a comprehensive solution designed to automate compliance and policy management for businesses. Powered by artificial intelligence, Termio streamlines the creation, analysis, and verification of policies, ensuring businesses stay compliant effortlessly. With easy registration, simple implementation of cookie and trust badges, and powerful API integrations, Termio enhances customer trust and engagement. By focusing on transparency and trust, Termio helps businesses improve conversion rates, customer lifetime value, and overall reputation.
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