Profile Details

Create Project

★★★★★

☆☆☆☆☆

USD 100 /hr

★★★★★

☆☆☆☆☆

Hire Andrei L.

Romania

USD 100 /hr

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

Profile Summary

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.

Subject Matter Expertise

• ☆ 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

Services

• 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

Work Experience

Freelance AI Solutions Architect

Aiudit

October 2025 - Present

Deputy Manager - Quality Assurance

TERAPIA

April 2025 - October 2025

Education

Biostatistics and Bioinformatics

University of Medicine and Pharmacy of Cluj-Napoca - Romania

October 2025 - Present

Engineering in Biotechnology

Babes-Bolyai University of Cluj-Napoca - Romania

October 2019 - June 2023

Certifications

• Certification details not provided.