- About Us
- What We Do
- How We Heal
- Products
- Cartilage Repair Device
- Medeor™ Matrix for Soft Tissue Repair
- Meso BioMatrix™ Scaffold for Soft Tissue Repair
- Epi-Guide® Bioresorbable Barrier Matrix
- OsseoFit™ Porous Tissue Matrix™
- Vitoss® Scaffold Foam™ Products
- Angio-Seal™ Vascular Closure Device
- QuickCat™ Extraction Catheter
- ThromCat® Thrombectomy System
- Technology Platforms
- How We Partner
- Investor Relations
Regulatory Filing and Support
Kensey Nash's experienced clinical and regulatory affairs staff has a proven track record of achieving U.S. and foreign regulatory approvals. Implementing our regulatory strategy has involved conducting large and small-scale clinical trials with leading medical institutions throughout the world.
Whether seeking regulatory approval independently or in collaboration with our valued sales partners, Kensey Nash can provide:
- Regulatory strategy consultation
- U.S. and International regulatory filing
- Clinical evaluation reports per ISO 14155
- Clinical investigation plan development, and trial management
