Medical Device Compliance Management Template

Medical Device Compliance Management in Priority Matrix

Manage and track compliance tasks to meet regulatory standards in the medical devices industry.

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Proposed Tasks

Critical and Immediate

• Task 1: Develop a Compliance Calendar due in 1 week
  ☐ Identify all regulatory deadlines ☐ Create a calendar with these deadlines
• Task 2: Audit Current Compliance Status due in 2 weeks
  ☐ Conduct an internal audit of current compliance status ☐ Identify areas of non-compliance
• Task 7: Conduct Regular Compliance Audits due in 7 weeks
  ☐ Develop a schedule for regular internal compliance audits ☐ Conduct the first audit
• Task 9: Maintain Documentation due in 9 weeks
  ☐ Ensure all compliance-related documentation is kept up-to-date ☐ Store documentation in a secure and accessible location
• Task 10: Prepare for External Audits due in 10 weeks
  ☐ Prepare all necessary documentation for external audits ☐ Ensure staff are prepared for external audits
• Task 14: Address Non-Compliance Issues due in 14 weeks
  ☐ Identify any areas of non-compliance ☐ Develop a plan to address these issues
• Task 19: Conduct Second Compliance Audit due in 19 weeks
  ☐ Conduct a second internal compliance audit

Critical but not Immediate

• Task 3: Develop Compliance Procedures due in 3 weeks
  ☐ Create detailed procedures for achieving and maintaining compliance ☐ Ensure procedures are accessible and understandable to all relevant staff
• Task 5: Conduct Compliance Training due in 5 weeks
  ☐ Develop a training program for compliance procedures ☐ Conduct the training program
• Task 6: Implement Compliance Monitoring due in 6 weeks
  ☐ Develop a system for monitoring compliance on an ongoing basis ☐ Implement the monitoring system
• Task 17: Review Regulatory Standards due in 17 weeks
  ☐ Review current regulatory standards to ensure continued compliance
• Task 18: Update Compliance Procedures due in 18 weeks
  ☐ Update compliance procedures based on changes to regulatory standards

Not Critical but Immediate

• Task 4: Communicate Procedures to Staff due in 4 weeks
  ☐ Hold a staff meeting to communicate new procedures ☐ Provide written procedures to all staff
• Task 13: Conduct Staff Compliance Surveys due in 13 weeks
  ☐ Develop a survey to measure staff understanding of compliance procedures ☐ Conduct the survey
• Task 16: Communicate Compliance Updates to Staff due in 16 weeks
  ☐ Communicate any changes in compliance procedures or regulations to staff

Not Critical or Immediate

• Task 8: Review and Update Procedures due in 8 weeks
  ☐ Review the effectiveness of compliance procedures ☐ Update procedures as necessary based on review
• Task 11: Update Compliance Calendar due in 11 weeks
  ☐ Update the compliance calendar with new deadlines as they become known
• Task 12: Review Compliance Training due in 12 weeks
  ☐ Review the effectiveness of compliance training ☐ Update training as necessary based on review
• Task 15: Review and Update Compliance Monitoring due in 15 weeks
  ☐ Review the effectiveness of compliance monitoring ☐ Update monitoring procedures as necessary based on review
• Task 20: Review Project Success due in 20 weeks
  ☐ Review the success of the compliance management project ☐ Make any necessary adjustments for future compliance management