Bioexcel Medical Device Research Organisation offer
Materiovigilance
Ensuring Medical Device Safety and Compliance
What is Materiovigilance?
We track, investigate, and report adverse events to regulatory authorities in compliance with global standards.
Key Features:
- Real-time monitoring of adverse events and incidents.
- Root cause analysis and risk assessment.
- Timely reporting to EU MDR, FDA, and CDSCO.
We conduct thorough investigations of reported incidents and implement corrective actions to mitigate risks.
Key Features:
- In-depth analysis of device failures and adverse outcomes.
- Recommendations for corrective and preventive actions (CAPA).
- Communication with regulatory bodies for field safety corrective actions (FSCA).
We prepare detailed PSURs for Class IIa, IIb, and III devices, summarizing safety and performance data over time.
Key Features:
- Compilation and analysis of adverse event data.
- Trend and signal detection for emerging risks.
- Submission to Notified Bodies as per EU MDR requirements.
We design and implement PMS plans to evaluate your device’s real-world performance and safety.
Key Features:
- Development of PMS plans and reports.
- Real-world evidence (RWE) collection and analysis.
- Feedback integration for device improvements.
CASE STUDY
Case Study 1: Adverse Event Reporting for a High-Risk Implant
Challenge :
A global manufacturer of Class III orthopedic implants faced an increase in adverse event reports, raising concerns about device safety.
Solution by Bioexcel:
- Conducted root cause analysis for the reported incidents.
- Implemented real-time adverse event tracking and reporting protocols.
- Prepared a Field Safety Notice (FSN) to inform healthcare providers and patients.
Outcome:
- Mitigated risk with a 40% reduction in incident recurrence.
- Enhanced trust and compliance with regulatory authorities.
A global manufacturer of Class III orthopedic implants faced an increase in adverse event reports, raising concerns about device safety.
Solution by Bioexcel:
- Conducted root cause analysis for the reported incidents.
- Implemented real-time adverse event tracking and reporting protocols.
- Prepared a Field Safety Notice (FSN) to inform healthcare providers and patients.
Outcome:
- Mitigated risk with a 40% reduction in incident recurrence.
- Enhanced trust and compliance with regulatory authorities.
Case Study 2: PSUR Preparation for a Diagnostic Device
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:
- Compiled data from real-world use, adverse events, and user feedback.
- Performed trend analysis to identify potential safety concerns.
- Submitted the PSUR to the Notified Body within the regulatory timeline.
Outcome:
- Maintained CE marking with no major findings.
- Strengthened product safety profile and user confidence.
An IVD manufacturer needed to prepare a Periodic Safety Update Report (PSUR) for their diagnostic kit to meet EU MDR requirements.
Solution by Bioexcel:
- Compiled data from real-world use, adverse events, and user feedback.
- Performed trend analysis to identify potential safety concerns.
- Submitted the PSUR to the Notified Body within the regulatory timeline.
Outcome:
- Maintained CE marking with no major findings.
- Strengthened product safety profile and user confidence.
Case Study 3: Field Safety Corrective Action for a Wound Care Product
Challenge :
A suture manufacturer detected an increased rate of breakage during use, requiring an urgent FSCA to address the issue.
Solution by Bioexcel:
- Coordinated with regulatory authorities for FSCA implementation.
- Designed and executed a product recall campaign.
- Provided recommendations for product redesign and revalidation.
Outcome:
- Successfully managed a recall with minimal market disruption.
- Enhanced product design and regained market trust.
A suture manufacturer detected an increased rate of breakage during use, requiring an urgent FSCA to address the issue.
Solution by Bioexcel:
- Coordinated with regulatory authorities for FSCA implementation.
- Designed and executed a product recall campaign.
- Provided recommendations for product redesign and revalidation.
Outcome:
- Successfully managed a recall with minimal market disruption.
- Enhanced product design and regained market trust.
Why Partner with Bioexcel?
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.
Frequently Asked Questions
How are medical device trials different from drug trials?
Medical device trials focus on demonstrating safety, performance, and usability rather than pharmacokinetics or dosing, as in drug trials. Device trials also often involve fewer phases but require iterative design validation and real-world testing.
