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Platform & Services

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What regulatory markets does Formly currently support?

Formly primarily supports the EU (MDR) and FDA markets, with plans to add support for Health Canada and MDSAP by the end of 2025. The platform has specific features for both MDR and IVDR compliance in Europe, along with comprehensive FDA submission preparation tools.

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What are the key features of Formly’s platform?

Formly offers an AI-embedded regulatory compliance platform with features including:
  • Pre-built SOPs and documentation templates customized to device type
  • AI-powered risk assessment and technical documentation generation
  • Visual roadmap interface based on device classification and target markets
  • QMS documentation management with approval workflows
  • Document control system with version tracking
  • Change management with automated impact analysis
  • Training management with document-linked records
  • Requirements traceability matrices
  • Export capabilities to PDF and editable formats

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How does the AI-assisted document generation work?

Formly uses multiple AI models for different tasks: GPT for language crafting and general content, Anthropic for technical documentation and requirements, and Gemini Pro for scientific content and web-integrated research. The system focuses on small, precise AI tasks to maintain accuracy, with a target accuracy of 90-95%. All AI suggestions require human review and verification before finalization.

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How does Formly handle data security and GDPR compliance?

Formly is fully GDPR-compliant with servers based in France (EU). The platform implements data processing agreements for confidentiality, and no client data is used for AI training. The system encrypts device-specific data and maintains strict separation between different companies’ information, ensuring no data sharing occurs between clients.

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Can Formly integrate with existing tools like Jira or Confluence?

Formly is developing integration capabilities with Jira, Confluence, and GitHub. Currently, the platform offers manual options for working with external systems, including document export/import capabilities, reference to external documents within the system, and custom document IDs for cross-referencing. Direct export functionality to Confluence for approved documentation is in development.

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Regulatory Process

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How long does the certification process typically take when using Formly?

Timelines vary by device classification and market, but Formly generally helps companies get to market 10x faster than traditional approaches. For Class I devices, the documentation can typically be completed in 6-8 weeks with dedicated focus, with some teams completing it in 4-6 weeks. For higher-class devices, the total certification process (including regulatory review) ranges from 9-12 months.

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Does Formly help with specific regulatory pathways like De Novo or 510(k)?

Yes, Formly supports various regulatory pathways including 510(k) submissions with a built-in 510(k) builder that includes XML export functionality. The platform also helps with De Novo pathway submissions by creating appropriate documentation and guiding users through the process. For complex submissions, the Premium and Virtual CRO service tiers provide expert guidance on selecting and navigating the most appropriate regulatory pathway.

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How does Formly handle documentation updates and change management after certification?

Formly includes a comprehensive change management system that tracks document dependencies and provides AI-assisted impact analysis when changes are made. The system can automatically update related documents based on changes, generate change reports, and manage the review and approval workflow. Post-certification options include continued software access for ongoing compliance management or a more affordable “hibernate mode” for basic maintenance.

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Implementation & Support

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What level of regulatory expertise is required from our team?

Formly is designed to work for teams with varying levels of regulatory experience. The platform guides users through the compliance process with AI assistance, making it accessible to those without deep regulatory expertise. For teams needing additional support, the Premium service tier includes expert consulting, and the full-service Virtual Chief Regulatory Officer option provides complete documentation creation and regulatory decision-making support.

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What support options are available during the certification process?

Formly offers multiple support tiers:
  1. Basic Plan: Self-managed software access with technical assistance for basic questions
  2. Premium Plan: Adds 4 hours of monthly consulting, direct expert chat access via Discord, and 24/7 support with ~1 day response time
  3. Virtual CRO Service: Full regulatory team replacement with hands-on system setup and complete documentation creation
All plans include unlimited user seats, with pricing based on device classification rather than user count.

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Company & Experience

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How many clients does Formly currently serve and what’s your success rate?

As of mid-2025, Formly serves approximately 30 clients, with 7 having achieved certification in Europe and 5 actively pursuing FDA submission. The company has experience with various device types, including software as medical device (SaMD), IVDs, and hardware products. The team behind Formly has previously completed 35 conformity assessments prior to launching the platform.