Post-market surveillance (PMS):
After placing the product in the market, an essential regulatory requirement is PMS.
We support you:
- To develop and implement the PMS plan
- To generate the PMS report or Periodic Safety Update Report based on findings
Vigilance:
In order to improve the protection of the end-user, a traceable vigilance system must be established by the legal manufacturer to track any safety issue related to the use of a released product.
We can act as a long term compliance partner to your company:
- To distinguish between the reportable and non-reportable incidents
- To communicate with the appropriate competent authority and help you to determine if the Field Safety Corrective Action (FSCA) is required or not.
- Create vigilance reports as well as Field Safety Notices (FSN)
- Ensure that the reportable incidents are communicated on time to the authorities and the end user.