プロフィール詳細

プロジェクトを作成

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Andrei L.に依頼

Romania

Medical AI Solutions Architect | EU AI Act & MDR Compliance Expert | Custom RAG & Python Developer

プロフィール概要

I bridge the gap between clinical requirements and advanced AI architecture. With a strong background in Healthcare & Medicine and deep technical expertise in Python, FastAPI, and Vector Databases, I specialize in building deterministic AI engines (RAG, Azure OpenAI., Mistral) for the MedTech and Pharma sectors. I also provide rigorous technical gap analysis for EU AI Act and Medical Device Regulation (MDR) compliance. Whether you need to build a secure health-tech application or ensure your current AI model meets European regulations, I deliver production-ready code and compliant architectures.

専門分野

• ☆ Data Analysis
• ☆ Artificial Intelligence
• ☆ Medical Devices
• ☆ Post-Market Surveillance
• ☆ Medical Device Development
• ☆ Medical Device Validation
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ EU In vitro Diagnostic Regulation (IVDR) Compliance

サービス

• Writing
• Research
• Consulting
• Data & AI
• Product Development

Writing Clinical Trial Documentation, Non-Medical Regulatory Writing, Business & Legal Writing

Research Gap Analysis, Scientific and Technical Research

Consulting Regulatory Consulting

Data & AI Statistical Analysis, Algorithm Design-ML, Big Data Analytics

Product Development Quality Assurance & Control (QA/QC), Product Compliance

職務経験

Freelance AI Solutions Architect

Aiudit

10月 2025 - 現在

Deputy Manager - Quality Assurance

TERAPIA

4月 2025 - 10月 2025

学歴

Biostatistics and Bioinformatics

University of Medicine and Pharmacy of Cluj-Napoca - Romania

10月 2025 - 現在

Engineering in Biotechnology

Babes-Bolyai University of Cluj-Napoca - Romania

10月 2019 - 6月 2023

認定資格

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