TS Quality & Engineering SRL

TS Quality & Engineering is an ISO 13485 medical device consulting company, supporting manufacturers with end-to-end (E2D) services across the entire medical device lifecycle:

🔬 R&D & Design Control

⚙️ Quality Management Systems

📋 QARA strategy & implementation

🇪🇺 MDR & IVDR compliance

🇺🇸 FDA strategy & submissions

🧪 Clinical Evaluation & CER/CEP

🤝 CRO services & clinical support

🌐 Global regulatory registrations

📁 eIFU

🤖 AI tools for Risk Management & EUDAMED