We provide expert regulatory, clinical and compliance services to Pharmaceutical medical device manufacturers.
Our Services Include The Following:
- Preparation and submission of Regulatory documentation including
- Technical Files
- Design Dossiers
- Regulatory and Technical review and consulting
- Preparation and submission of registration for product applications
- Medical device vigilance and reporting systems
- Regulatory and manufacturing compliance
- Strategic and regulatory planning
- Regulatory/Quality GAP Analysis
- Interpretation of guidance documents and legislation
- Assistance with device labeling requirements
- Provide medical device classification