Regulatory Compliance Management Template

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Stay on top of regulatory compliance in the medical device industry with this comprehensive template. It helps you keep track of all regulatory tasks, from updating compliance calendars to preparing for audits and training staff.

This template ensures that you meet all regulatory standards and deadlines, reducing risks and maintaining the highest quality standards for your medical devices.

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Regulatory Compliance Management for Priority Matrix

Regulatory Compliance Management in Priority Matrix

Ensure timely and compliant completion of all regulatory tasks in the medical device industry.

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Proposed Tasks

Critical & Immediate

  • Update Compliance Calendar - due in 1 day
    ☐ Review all current and upcoming regulations ☐ Identify deadlines ☐ Update compliance calendar
  • Review New FDA Guidelines - due in 1 week
    ☐ Study the new FDA guidelines ☐ Identify areas of impact ☐ Plan for implementation

Critical & Long-Term

  • Revise Quality Management System - due in 2 weeks
    ☐ Identify areas for improvement ☐ Revise procedures and processes ☐ Train staff on changes
  • Conduct Internal Audit - due in 1 month
    ☐ Prepare audit plan ☐ Conduct audit ☐ Address findings
  • Prepare for External Audit - due in 3 months
    ☐ Review previous audit findings ☐ Correct any non-compliance issues ☐ Prepare necessary documentation
  • Update Risk Management Plan - due in 4 months
    ☐ Identify new risks ☐ Update risk management plan ☐ Communicate changes to all stakeholders
  • Prepare for ISO Certification Renewal - due in 6 months
    ☐ Review ISO standards ☐ Prepare necessary documentation ☐ Address any non-compliance issues

Non-Critical & Immediate

  • Monitor Regulatory Changes - ongoing task
    ☐ Monitor FDA and other regulatory bodies for changes ☐ Assess impact on business ☐ Implement necessary changes

Non-Critical & Long-Term

  • Review Supplier Compliance - due in 2 months
    ☐ Review supplier compliance records ☐ Address non-compliance issues ☐ Update supplier list if necessary
  • Staff Training on Regulatory Compliance - due in 6 months
    ☐ Prepare training materials ☐ Conduct training sessions ☐ Assess staff understanding