Medical Devices Regulatory Intelligence

We provide regulatory intellect consulting for product launch strategy to your Medical Device from a global perspective. The scope of the service includes scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.  Our report will establish a “reasonable assurance of safety and effectiveness,” as demonstrated by valid scientific evidence. The deliverable will be cost effective with a high level of accuracy and precision.

Our Expertise

• Pre-Market authorization to pass through scrutiny procedures
• Quality assurance auditing and compliance
• Review for Device description and specifications
• Procedural Intelligence
• Tracking competitor products across therapeutic classes