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Ostravic is a regulatory compliance practice helping AI and MedTech scaleups navigate the EU AI Act, EU MDR, and ISO 42001 as they expand into European markets.
We specialize in dual-framework regulatory work — where AI governance and medical device regulation overlap, teams often address each in isolation, creating documentation gaps and duplicated effort. We help close that gap.
What we deliver:
EU AI Act & MDR classification opinions
Gap analysis against EU AI Act, ISO 42001, or MDR requirements
FRIA / DPIA foundational assessments
Regulatory documentation and technical file support
Founded by Sushant Humane, whose background combines pharmaceutical regulatory science (M.Pharm, published research in formulation design) with hands-on work translating complex EU frameworks into clear, actionable documentation for founders and engineering teams.
We work with fast-moving scaleups who need practical, structured deliverables — not lengthy general advice — especially ahead of enterprise deals, investor due diligence, or upcoming regulatory deadlines.
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Min project size
$1,000+
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Hourly rate
$50 - $99 / hr
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Employees
2 - 9
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Year founded
Founded 2026
Service Lines
- Compliance Consulting
- 60%
- AI Consulting
- 40%
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