We don't hand you passive checklists or overcharge for legal hours—we embed directly into your codebases, CI/CD pipelines, and clinical protocols to build audit-ready EU AI Act and MDR compliance, helping you pass enterprise procurement and close deals fast.
We don't hand you theoretical slide decks. Our regulatory software engineers embed in your codebases, pipelines, and clinical protocols to guarantee compliance.
Full Title III High-Risk systemic execution, algorithmic transparency logging, automated training data governance, bias audits, and post-market monitoring engines.
Harmonized CE-Mark medical device regulation compliance for standalone AI, diagnostic software, and clinical decision support systems (CDSS).
Turn compliance friction into a competitive closing asset for tier-1 European enterprise sales, cross-border tenders, and sovereign data security audits.
Zero theoretical delays. Our compliance software engineers write directly into your CI/CD pipelines, Docker manifests, and ML testing harnesses.
Deterministic AST scans of model repositories, data lineage maps, and training datasets to pin exact Title III High-Risk or MDR Rule 11 classification.
Commit Art. 12 algorithmic event-logging hooks, drift watchers, and human-in-the-loop oversight gates directly into production branches.
Generate auditor-grade technical documentation files, FRIA impacts, and ISO 13485 verification dossiers straight from code artifacts.
Our principal regulatory engineers sit side-by-side with European auditors and enterprise buyers to defend architecture telemetry and seal sign-off.
See how Ostravic turns ambiguous European directives into concrete engineering assets compared to Big Law advisory and empty compliance SaaS.
| Compliance Dimension |
Ostravic Sovereign Execution
BUILT-IN CODE
|
Big Law & Advisory | Compliance SaaS |
|---|---|---|---|
| Technical File Creation |
Full production-ready Annex IV documentation written by systems engineers directly into code repos.
|
High-level recommendations memo leaving execution entirely to your engineering team. | Unfilled generic spreadsheets and disconnected Google Docs templates. |
| CI/CD & Pipeline Integration |
Automated test suites, drift monitors, & guardrails committed directly to your Git repositories.
|
No code integration; zero software tooling or engineering expertise provided. | Manual ad-hoc checks forgotten before major production deployments. |
| Clinical & Data Validation |
Empirical bias metrics, adversarial boundary testing, and real clinical performance verification.
|
Theoretical review of statistical samples with zero code execution. | Subjective self-attestation guesswork with high audit rejection risk. |
| Notified Body Defense |
We sit with the auditor live and defend your technical architecture, telemetry, and mathematical proofs.
|
Billable advisory hours during inspection; zero technical liability assumed. | CTO left completely alone under intense regulatory scrutiny. |
| Turnaround Speed |
2 to 4 week comprehensive execution sprint to full sign-off.
|
6 to 9 months billable discovery and endless stakeholder meetings. | Stalled indefinitely due to competing internal engineering roadmaps. |
| Cost & Financial Model |
Fixed-scope execution sprint with milestone deliverables guaranteed.
|
Open-ended legal billing (€750–€1,200/hr) with unpredictable budget caps. | $40k–$80k/year recurring SaaS license + 500 hours of internal engineering work. |
Receive a deterministic breakdown of your AI classification under the EU AI Act (Title III High-Risk vs Minimal Risk) or MDR SaMD classification rule set.
Your deterministic compliance evaluation has been compiled. Our lead regulatory systems engineer has received your parameters and will deliver the technical file roadmap within 15 minutes.