EU Rep / Swiss Rep / UK Rep

EU Rep / Swiss Rep / UK Rep

Regulatory Affairs, Regulatory Certifications

Information

We provide full European market access at a competitive price through our integrated services as European Authorized Representative, Swiss Authorized Representative, and UK Responsible Person. 📩 Reach out at info@tsquality.ch
TS Quality & Engineering SRLNP2.B64TS 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

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