Automated Device Labeling Compliance Verification

import { Mixpeek } from 'mixpeek';

const client = new Mixpeek({ apiKey: process.env.MIXPEEK_API_KEY });

// Configure market-specific requirements
await client.compliance.configureRules({
  rule_set: 'medical-device-labeling',
  markets: {
    'eu-mdr': {
      required_symbols: ['CE', 'UDI', 'manufacturer', 'single_use'],
      required_content: ['intended_use', 'warnings', 'contraindications'],
      languages: ['en', 'de', 'fr', 'it', 'es'],
      date_format: 'DD/MM/YYYY'
    },
    'fda-us': {
      required_symbols: ['manufacturer', 'lot_number', 'expiry'],
      required_content: ['indications', 'warnings', 'directions'],
      languages: ['en'],
      date_format: 'MM/DD/YYYY'
    }
    // Additional markets...
  }
});

// Verify label compliance
async function verifyLabelCompliance(labelImageUrl: string, config: {
  product_id: string;
  target_markets: string[];
  label_type: 'primary' | 'secondary' | 'ifu';
}) {
  const analysis = await client.compliance.verifyLabel({
    url: labelImageUrl,
    rule_set: 'medical-device-labeling',
    markets: config.target_markets,
    checks: [
      'required_symbols',
      'symbol_placement',
      'required_content',
      'language_completeness',
      'translation_accuracy',
      'date_format',
      'udi_format'
    ]
  });

  return {
    overall_status: analysis.compliant ? 'pass' : 'fail',
    market_results: analysis.by_market,
    issues_found: analysis.issues,
    recommendations: analysis.fixes
  };
}

// Get portfolio compliance status
async function getPortfolioCompliance() {
  const status = await client.compliance.getPortfolioStatus({
    rule_set: 'medical-device-labeling',
    group_by: ['product_family', 'market']
  });

  return {
    compliant_labels: status.compliant_count,
    non_compliant: status.non_compliant_count,
    by_market: status.market_breakdown,
    by_issue_type: status.issue_breakdown,
    upcoming_deadlines: status.requirement_changes
  };
}