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Changelog

Product Updates

Follow along as we build the future of post-market surveillance. New features, improvements, and what is coming next.

March 2026

Shipped

Launch

  • Automated FDA MAUDE data ingestion for medical device product codes
  • AI-powered adverse event summarization with Claude
  • Human-in-the-loop review queue for compliance documentation
  • Competitor device monitoring and tracking
  • Signal detection dashboards with severity and failure mode analytics
  • PSUR-ready trend reports and PDF exports
  • Weekly email digests with safety signal summaries
  • Slack and webhook notification integrations
  • 21 CFR Part 11 compliant audit trails and access controls
  • Role-based team management with session timeouts

April 2026

Coming Soon

Coming in April

  • Literature surveillance integration
  • Custom report templates
  • Enhanced signal detection algorithms
  • Bulk event export functionality

On the Roadmap

Planned

Future Plans

  • Multi-source data ingestion (MHRA, BfArM, TGA)
  • AEMS migration support
  • Custom CAPA workflow integration
  • Advanced NLP models for device-specific terminology
  • SOC 2 Type II certification

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