Clinical & Regulatory Support

Clinical & Regulatory Support

For large-scale projects, Creganna-Tactx Medical can manage the complete clinical, approval & post market process for your product. Services are provided for Class II & III medical devices, specializing in minimally invasive therapies. 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 team co-located with our expert partner Boston Biomedical Associates.

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

 

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