Streamline EU Medical Device Certification with Formly's AI

Streamline your EU medical device certification with Formly's AI-powered platform. Get fast CE marking through automated documentation and expert regulatory support.

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Updated on Nov 26, 2025 (2 months ago)

AI Automation Streamlines EU Medical Device Certification with Formly

AI automation is revolutionizing industries, and healthcare is no exception. Introducing Formly, an innovative AI-powered software platform designed to simplify the complex process of obtaining CE marking for medical devices in the EU. Formly empowers businesses by automating documentation workflows and providing expert regulatory guidance, significantly reducing time and resources required for certification. With Formly, manufacturers can accelerate their product launch timelines, navigate regulatory complexities with ease, and focus on developing life-saving innovations.

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Formly offers a comprehensive platform for managing medical device compliance, including documentation creation, regulatory guidance, and quality management system tools. While they provide a free trial and expert guidance, the pricing details are not explicitly stated on their website. They highlight key features like AI-powered documentation generation, ISO 13485 compliance support, and customizable workflows, suggesting a tiered pricing structure based on usage or feature sets. Key Points: Focus: Medical device compliance management Features: Documentation creation (AI-powered), Regulatory guidance, Quality Management System tools (ISO 13485 compliant) Pricing: Not explicitly stated on the website, likely tiered based on usage or features. Free Trial & Guidance: Offered to potential customers Target Audience: Startups and companies developing medical devices

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