PDF to EPUB3 for
Healthcare & Medical Devices

Convert Instructions for Use (IFU), clinical guidelines, and patient documentation to WCAG 2.1 AA-compliant EPUB3. Built for medical device manufacturers, healthcare publishers, and compliance teams facing EAA 2026 enforcement and EU MDR/IVDR accessible IFU requirements.

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MDR/IVDR + EAA compliance

Digital IFUs must satisfy WCAG 2.1 AA under EAA enforcement (active June 28, 2026). EPUB3 is the accessible IFU format — reflowable at any zoom, screen reader compatible, no horizontal scrolling at 400%.

IFU layout handling

Multi-column warning notices, symbol tables (ISO 15223-1), step-by-step instruction tables, and specification grids are linearised into correct reading order with full heading structure.

Multi-language batch conversion

A Class IIa device with 27 EU language versions produces 27 IFU PDFs per update. API conversion processes all language versions in under 20 minutes at $29/month.

Dual-format distribution

Keep the PDF for print packaging, notified body submission, and regulatory filing. Distribute EPUB3 digitally via QR code, device website, or patient portal. Both formats from one conversion workflow.

ACE by DAISY validation

EPUB3 output passes ACE by DAISY automated validation — producing WCAG 2.1 AA conformance reports for ISO 13485 QMS records and national market surveillance authority audits.

EAA enforcement is live

EAA enforcement began June 28, 2026. MDR/IVDR and EAA requirements converge for patient-facing digital IFUs. Device manufacturers distributing IFUs digitally to EU consumers are in scope now.

Healthcare and medical device use cases

Medical device manufacturers converting patient-facing IFU PDFs to accessible EPUB3 for EAA and MDR compliance
Class III and IIb device companies providing ACE-validated EPUB3 for notified body documentation
Healthcare publishers converting clinical guidelines, drug monographs, and treatment protocols
Hospital systems and NHS trusts converting patient information leaflets for digital accessibility compliance
Combination product manufacturers generating accessible documentation for drug and device components
Medical device regulatory affairs teams documenting accessible IFU distribution in post-market surveillance records

Pricing for healthcare teams

Free tier — evaluate with real IFU documents, no account required
Pro — $9/month, unlimited conversions
API — $29/month, 100 requests/hour, batch multi-language IFU conversion
Premium Verification — $49+/document for human-reviewed certified output with full ACE report

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Representative use case: Pharmaceutical PIL compliance

Representative example based on a typical PIL compliance scenario — not a named customer testimonial.

Pharmaceutical Company — 7,820 Patient Information Leaflets

Representative use case

Pharmaceutical company, 340 approved products across EU markets. PILs are regulated two-column documents distributed digitally via EMA portal, corporate website, and pharmacy dispensing systems. 23 EU language versions × 340 products ≈ 7,820 documents in scope. EMA readability guidelines mandate the two-column layout that PDF cannot reflow.

Metric	Outcome
Documents converted	7,820 PILs
Manual conversion cost estimate	€625,000–€1,564,000
toolkit.bot cost	$58 ($29/month × 2 months)
WCAG 1.4.10 Reflow conformance	100% of PIL catalogue
ACE by DAISY pass rate	91% (remainder: figure alt-text, queued for human review)
Conversion time	~54 hours async batch

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PDF to EPUB3 forHealthcare & Medical Devices