In accordance with current legislation, all manufacturers must have a post-marketing monitoring system appropriate to the type of risk and the type of medical device in question.
The aim is to demonstrate that products manufactured in series production continue to comply with the principles of safety and operation with which they were authorized.
The manufacturer has to minimize the risks and preventing incidents related to the products. Also, will have systems for:
- Risk management.
- Report incidents and corrective safety actions.
QUALIPHARMA MEDICAL DEVICES give global support to its clients through customized solutions focused to:
- Preparation of the Post-Marketing Monitoring Plan (PMS).
- Monitoring, compilation and evaluation of information on the clinical use of the producto.
- Periodic Safety Report (PSUR).
- Post-marketing clinical follow-up (PMCF).
- Notification of adverse reactions and corrective actions.
- Trends reports.