At Umbra Quality Systems, we recognize that ensuring the safety and compliance of medical devices is paramount. Our Material Vigilance services are designed to provide risk mitigation measures and ensuring the highest standards of safety and compliance.
The Significance of Material Vigilance
Materiovigilance is defined as a combined system of performance characterization, monitoring, identifying, collecting, reporting, and analyzing any untoward occurrence caused by medical devices. Materialvigilance aims to improve the protection of health and safety of patients, healthcare professionals, and other users by reducing the likelihood of reoccurrence of incidents related to the use of a medical device.
Our Comprehensive Materialvigilance Solutions
1. Risk Assessment and Mitigation:
Conduct thorough risk assessments to identify potential hazards associated with medical devices and implement effective mitigation strategies.
2. Regulatory Compliance Checks:
Ensure that medical devices in the market meet regulatory safety standards and requirements..
3. Product Specifications:
Define the suitable product specifications for medical devices to market, procure and/ or supply.
4. Continuous Monitoring and Reporting:
Facilitate continuous monitoring for the identification, collection, reporting and analysis of any untoward occurrences caused by medical devices.
Follow up & reporting of any field safety corrective actions.
Trend reporting of any statistically significant increase in the frequency or severity of incidents that are not serious incidents or that are expected undesirable side effects that could have a significant impact on the benefit-risk analysis of the medical devices.