Clinical & Regulatory Support
For large-scale projects, TE Connectivity can manage the complete clinical, approval & post market process for your product.
Services are provided for Class II & III medical devices. Your product can be supported for multiple approval pathways and regulatory bodies worldwide. Our clinical, regulatory and quality consulting services are provided by a dedicated & experienced in-house team.
Services provided include:
- Regulatory Affairs & Quality Assurance
- Regulatory & Clinical Strategy Development
- Clinical Research – trial management & monitoring
- Data Management & Biostatistics
- Submission Preparation Service
- Approval Process Management
- Post Approval Services – field management
Sample Device Experience – Clinical & Regulatory Consulting
- Cardiac & Peripheral Stents
- Non Vascular Stents
- Balloon Catheters
- Percutaneous Heart Valves
- Ultrasonic Ablation
- Vena Cava Filters
- Vascular Grafts
- Thrombectomy
- Embolic Protection Systems
- Ventricular Assist Devices
- RF ablation/ EP systems
- Endoscopic Technologies
- Intravascular Ultrasound
- Urethral Bulking
- Laparoscopic Devices
- Cardiopulmonary Support
- Drug Delivery Technology
- Bariatrics