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Bioexcel Medical Device Research Organisation offer


Ensuring Safety at Every Stage

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.
  1. 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.
  1. 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.

     4 .Risk Assessment and Mitigation:

  • Bioexcel is dedicated to the assessment and mitigation of risks associated with medical devices.
  • We proactively identify potential risks through comprehensive risk assessments.
  • Our team works with clients to develop strategies for mitigating these risks, whether it involves product recalls, safety alerts, or design modifications.
  • Our risk management practices contribute to a safer and more reliable medical device landscape.
  1. Post-Market Surveillance:
  • Bioexcel emphasizes the importance of continuous post-market surveillance to ensure device safety and performance.
  • Our commitment to ongoing monitoring extends beyond market introduction, allowing us to detect and address safety concerns that may arise during real-world use.
  • We believe that post-market surveillance is crucial to maintaining patient safety and the reputation of medical device manufacturers.
  1. Collaboration with Regulatory Authorities:
  • Bioexcel values collaboration with regulatory agencies to ensure timely and accurate reporting of adverse events and safety concerns.
  • We work closely with regulatory authorities to provide the necessary information and address inquiries promptly.
  • Our collaboration reinforces the credibility of our Materiovigilance services and supports the broader goal of patient safety.
Help & FAQ

Frequently Asked Questions

Materiovigilance is the systematic collection, monitoring, and reporting of adverse events and incidents associated with medical devices. It is crucial for patient safety as it helps identify and mitigate potential risks and ensures the ongoing safety and performance of medical devices post-market.

Bioexcel employs a structured process for adverse event reporting, including data collection, assessment, documentation, and timely reporting to regulatory authorities when required. This systematic approach ensures the comprehensive tracking of device-related incidents.

Bioexcel's Materiovigilance experts are proficient in data analysis, enabling them to identify trends, patterns, and safety issues associated with medical devices. This expertise helps in making data-driven decisions and improving device safety.

Bioexcel's Materiovigilance services are designed to align with regulatory requirements in various markets. We monitor changes in regulations, ensure timely reporting, and maintain compliance, reducing the risk of regulatory non-compliance.

Bioexcel's Materiovigilance experts conduct risk assessments based on adverse event data and trends. When potential risks are identified, mitigation strategies are developed, and necessary actions are taken to enhance the safety and performance of medical devices.