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Medical Device Vigilance & EU MDR

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Medical Device Vigilance & EU MDR

Medical Device Vigilance & Safety Reporting Activities & Services

  • Support with end to end Incident Report Management (IRM) including: Incident processing, Medical Review, QC & Submission.
  • Handling Quality Complaints with & without safety incidents in USA, EU & worldwide.

Post Marketing Support Activities & Services

  • Create CER as per MEDDEV 2.7.1 Rev 4 including annual updates to all reports:
    • structured literature search, review and analysis.
    • Risk Benefit Assessment.
    • Equivalency approach.
    • Post Market Surveillance Data Analysis including Trend CER: Analysis, Non-Clinical/Clinical Data (bench, pre-clinical, sponsored studies/IIR & State of the Art
  • Support & create Post Marketing Surveillance Plan (PMS).
  • Support & create Post Marketing Clinical Follow-up Plan (PMCF) & Initial Report.
  • Support & create PSURs for Class II a & b and Class III devices.
  • Support & create Summary of Safety and Clinical Performance (SSCP).
  • Support & creation of Signal Detection and Incident Signal Evaluation Reports.
  • Support & create Risk Management Plans including Benefit Risk Assessment.

Medical Device Vigilance & Safety Reporting Activities & Services

  • Support with end to end Incident Report Management (IRM) including: Incident processing, Medical Review, QC & Submission.
  • Handling Quality Complaints with & without safety incidents in USA, EU & worldwide.

GAP-Analysis Activities & Services

  • Review of technical files & data to conduct effective gap and analysis.
  • Support and provide remediation plan for the gaps and address compliance.

Clinical Evidence Activities & Services

  • Support full service clinical evidence programs from advisory to implementation.
  • Support with Retrospective/ EMR data, Surveys, Literature and Registries set up.

Regulatory Strategy Activities & Services

  • Supporting Regulatory Strategy for Class I, II a & b & Class III.