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
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