Vivos Inc (RDGL)

[chereb19]

FACTS

It is generally recommended to create certification training for a new radiology device after successful completion of clinical trials. Here's why:

Benefits of waiting:

Safety and efficacy: Clinical trials ensure the device is safe and effective for its intended use. Training based on established safety and efficacy data provides users with better guidance and minimizes potential risks.


Standardized procedures: Clinical trials typically involve developing standardized protocols and procedures for using the device. These protocols can then be incorporated into the training, ensuring consistency and optimal use.


Data-driven training: Clinical trial data provides valuable insights into the device's performance and potential challenges. This data can be used to develop more comprehensive and targeted training content.


Regulatory compliance: Some regulatory bodies may require specific training for users of medical devices. By waiting until after clinical trials and regulatory approval, the training can ensure compliance with these requirements.