Medical Vigilance (Medical Vigilans)
Services in this category ▼
Medical Device Consultancy
What is medical vigilance?
Medical vigilance is the process of monitoring, evaluating, reporting, and preventing adverse events linked to the safety and performance of medical products. It runs across the full life cycle of a product once marketing authorisation has been granted, and delivers ongoing oversight of product safety and effectiveness.
How medical vigilance services are arranged
Medical vigilance is typically delivered by the manufacturers, importers, or distributors of medical products. It is a continuous activity once a product has a marketing authorisation. Organisations can run the process in-house through a vigilance department or engage a consultancy to handle it.
Which products the service covers
Medical vigilance applies to medical devices, pharmaceuticals, and related medical products with marketing authorisation. The scope covers adverse events, trends, and any safety signal that emerges from the field.
How Sistem Patent Kalite supports medical vigilance
Sistem Patent Kalite has a specialist team that manages medical vigilance start to finish. The service includes:
- Planning and executing the medical vigilance process
- Monitoring and evaluating adverse events
- Managing reporting and communication with the relevant authorities
- Consultancy on product safety and effectiveness
Working with Sistem Patent Kalite lets manufacturers and marketing authorisation holders keep product safety and effectiveness under professional oversight. The team tailors the service to the specific product family and regulatory profile.
