Practical Issues with Conducting Multi-National Clinical Trials for Medical Device Approval in the US

This webinar will cover essential elements of multi-national medical device clinical trials, help you understand US and non-US regulatory processes for medical device clinical trials and provide practical tips for assuring US market approval for your device.

Why Should You Attend:

Testing of medical devices raise unique regulatory, logistical and practical issues that need to addressed for successful completion of a given trial. The biggest challenge perhaps is conducting multi-national trials with medical devices primarily because medical devices are developed and regulated very differently in the US compared to the rest of the World.

Areas Covered in the Seminar:

This seminar will provide easy-to-master techniques to prepare perfect SOPs. Topics covered include

• Essential elements of medical device clinical trials: Device, protocol, sites, data.
• Comparison of US and non-US regulatory processes for medical device clinical trials.
• Concerns with non-US clinical data.
• Clinical trials with devices approved in other countries.
• Managing US-based and international clinical investigators.
• Using non-US clinical experience: retrospective data analysis.