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MedTech Solutions·Healthtech·
2024
·8 monthsAI Act Compliance for Health Data Platform
AI Act Consulting
Data Governance
Compliance Strategy
High-RiskControlled
Risk Classification
ISO 27001Achieved
Certification
-40%
Time to Market
100%
Documentation
The Challenge
A healthtech startup developing AI-powered diagnostic tools needed to navigate the new EU AI Act requirements while ensuring patient data protection.
Our Solution
We classified their AI systems under the AI Act framework, implemented appropriate conformity assessment procedures, established data governance protocols, and created comprehensive documentation for regulatory submissions.
Key Results
- Successfully classified as high-risk AI with proper controls
- Achieved ISO 27001 certification
- Obtained CE marking for medical device software
- Reduced time-to-market for new features by 40%
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