Regulatory Compliance & Medical Software
We build compliance into the architecture — not as an afterthought. From DiGA certification to GDPR auditing.
DiGA Development
Complete development of DiGA-certifiable applications per BfArM requirements. From evidence assessment to listing.
GDPR / Privacy Audit
Technical and organizational measures, processing records, Privacy by Design — audit-ready documentation.
EU AI Act Conformity
Risk classification, technical documentation, and conformity assessment for AI systems under EU regulation.
MDR-Compliant Design
Software as Medical Device (SaMD). Quality management system, clinical evaluation, technical documentation.
WCAG AA Accessibility
Accessibility testing and implementation per WCAG 2.2 AA. Automated and manual testing.
Audit Preparation
We prepare your software and documentation for external audits — TÜV, BfArM, BSI.
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