EU hospitals won't sign
without your AI documentation. We generate it.
Healthcare AI is explicitly listed in EU AI Act Annex III as high-risk. Every Indian HealthTech selling to EU needs Annex IV docs, Article 13 transparency statements, and post-market monitoring plans — or the deal doesn't close.
Healthcare AI is Annex III high-risk. EU hospitals know this. Indian HealthTech companies often don't
EU AI Act Annex III explicitly names medical device AI, clinical decision support, and patient-facing health AI as high-risk. This means every Indian HealthTech selling AI diagnostics, imaging analysis, or treatment recommendations to EU hospitals, clinics, or pharma companies must produce Annex IV technical documentation before the contract is signed.
EU hospital procurement committees are applying this requirement now — ahead of August 2026 enforcement. Indian HealthTech vendors without documentation are losing deals to EU-based competitors who have it. Fine exposure: up to €30M or 6% of global annual turnover.
Healthcare-specific Annex IV. Generated. Not templated.
Healthcare-specific Annex IV generation — all 8 sections with clinical AI context
Annex III classification for medical AI — diagnostic, screening, treatment recommendation systems
Article 13 transparency statements formatted for EU hospital procurement review
Post-market monitoring plan templates for clinical AI — aligned to EU MDR + AI Act requirements
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