MedTech Regulatory Compliance

Why MedTech Companies Choose SeekBee

Reduce Compliance Costs

Cut compliance-related expenses by up to 60% through automation and AI-powered insights.

Minimize Regulatory Risk

Avoid costly fines, recalls, and delays with 24/7 monitoring of regulatory changes.

Accelerate Time to Market

Streamline regulatory approval processes to get your medical devices to market faster.

Regulatory Intelligence

Our AI continuously monitors and analyzes regulatory changes from FDA, EMA, MHRA, and other global authorities, providing real-time alerts and actionable insights tailored to your specific products.

  • Real-time regulatory change detection
  • Impact analysis for your specific devices

Compliance Documentation

Automate the creation and maintenance of essential regulatory documentation, including Technical Files, Design History Files, and Clinical Evaluation Reports, reducing documentation time by up to 70%.

  • Automated document generation
  • Version control and audit trails

Gap Analysis

Identify compliance gaps in your current processes and documentation with our AI-powered analysis tools. Receive prioritized recommendations to address critical issues first.

  • Comprehensive compliance assessment
  • Risk-based prioritization

Risk Management

Streamline your risk management process in compliance with ISO 14971. Our platform helps identify, analyze, and mitigate risks throughout the product lifecycle.

  • ISO 14971-compliant risk assessment
  • Automated risk documentation

Intelligent Search

Quickly find relevant regulatory information across global regulations, guidance documents, and standards with our AI-powered search engine. Get answers, not just search results.

  • Natural language queries
  • Context-aware responses

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