Medical Device Vigilance, as known as Materiovigilance is a process of handling product complaints & safety issues of Medical Device to monitor medical device associated adverse event (MDAE) & Safety data of medical device to protect the health and ensure the safety of health users and other by reducing the recurrences of adverse events & Malfunctions.

      1. Adverse Event Reporting:

• Bioexcel systematic approach to adverse event reporting is the cornerstone of our Materiovigilance services.
• We work diligently to collect and report all adverse events and incidents related to medical devices to ensure a comprehensive understanding of safety concerns.
• Our process includes robust data collection, detailed documentation, and timely submission to regulatory authorities.
• Bioexcel commitment to adverse event reporting contributes to patient safety and regulatory compliance, fostering trust in the medical device industry.

2. Data Analysis:

• Data analysis is where Bioexcel excels in Materiovigilance. Our team of experts possesses the skills and tools to analyze data effectively.
• We go beyond collecting data and focus on identifying trends, patterns, and safety issues that may not be immediately apparent.
• Through rigorous analysis, we can proactively address safety concerns and continuously improve the quality of medical devices.
• Bioexcel data analysis expertise is an invaluable asset in ensuring patient safety and product quality.

3. Regulatory Compliance:

• At Bioexcel, we take regulatory compliance seriously. We understand the importance of adhering to regulatory requirements for adverse event reporting and safety monitoring.
• Our Materiovigilance services are designed to ensure full compliance with national and international regulations.
• We maintain transparency in reporting and adhere to strict timelines to meet regulatory standards.
• Bioexcel focus on regulatory compliance guarantees the integrity of the Materiovigilance process.