Clinical & Regulatory Support

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