At Bioexcel, we provide comprehensive materiovigilance services to monitor and manage the safety of medical devices throughout their lifecycle. Our systematic approach ensures compliance with global regulations, mitigates risks, and safeguards patient safety in real-world use.
What is Materiovigilance?
Materiovigilance is the science of monitoring and evaluating the safety of medical devices post-market to identify, assess, and manage adverse events and risks. It plays a critical role in preventing harm to patients and ensuring continuous compliance with regulations like EU MDR (2017/745) and FDA requirements.
Why Materiovigilance is Essential
Real-Time Surveillance for Enhanced Safety
We track, investigate, and report adverse events to regulatory authorities in compliance with global standards.
Key Features:
Comprehensive Evaluation for Corrective Action
We conduct thorough investigations of reported incidents and implement corrective actions to mitigate risks.
Key Features:
Ensuring Ongoing Compliance
We prepare detailed PSURs for Class IIa, IIb, and III devices, summarizing safety and performance data over time.
Key Features:
Continuous Monitoring Beyond Approval
We design and implement PMS plans to evaluate your device’s real-world performance and safety.
Key Features:
Proactive Safety Measures for Risk Management
We assist in identifying, planning, and executing FSCAs, including recalls, product modifications, or public safety notices.
Key Features:
Uncovering Trends to Enhance Safety
Our advanced data analysis techniques identify patterns and trends, enabling proactive risk management.
Key Features:
Challenge:
A global manufacturer of Class III orthopedic implants faced an increase in adverse event reports, raising concerns about device safety.
Solution by Bioexcel:
Outcome:
Challenge:
An IVD manufacturer needed to prepare a Periodic Safety Update Report (PSUR) for their diagnostic kit to meet EU MDR requirements.
Solution by Bioexcel:
Outcome:
Challenge:
A suture manufacturer detected an increased rate of breakage during use, requiring an urgent FSCA to address the issue.
Solution by Bioexcel:
Outcome:
Expert Knowledge
In-depth understanding of EU MDR, FDA, and CDSCO requirements.
Proactive Monitoring
Advanced tools and methodologies for real-time risk detection.
Global Reach
Experience managing materiovigilance activities across multiple regions.
Comprehensive Support
From adverse event reporting to FSCA execution, we handle it all.
Yes, materiovigilance is mandatory for all devices, especially high-risk and implantable devices, under EU MDR, FDA, and CDSCO regulations.
PMS involves broader post-market monitoring activities, while materiovigilance focuses specifically on detecting and managing adverse events and risks.
PSURs must be submitted annually for Class IIb and III devices and every two years for Class IIa devices under EU MDR.
Safeguard your medical device’s performance and compliance with Bioexcel’s expert materiovigilance services. Contact us today to ensure proactive risk management and global regulatory success.
TO BREAK THE BARRIERS OF TRADITIONAL CLINICAL INVESTIGATION FOR MEDICAL DEVICE INDUSTRY
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