Regulatory Compliance Management Template

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In the medical equipment industry, staying compliant with regulations is crucial to maintaining product marketability and avoiding legal issues. This template helps Managing Directors keep track of all compliance-related tasks and deadlines.

Utilize this template to identify key regulatory requirements, prepare for audits, develop training programs, monitor regulatory changes, and maintain up-to-date compliance policies and documentation.

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Regulatory Compliance Management for Priority Matrix

Regulatory Compliance Management in Priority Matrix

Stay ahead of regulatory requirements and deadlines to ensure your medical products remain compliant.

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Proposed Tasks

High Impact, Immediate

  • Monitor Regulatory Changes due in 1 week
    ☐ Subscribe to regulatory updates ☐ Review updates for relevancy ☐ Implement changes as necessary
  • Maintain Device Master Record due in 1 week
    ☐ Review Device Master Record ☐ Update with any changes ☐ Ensure accessibility
  • Identify Key Regulatory Requirements due in 1 month
    ☐ Research and list medical device regulations ☐ Identify related tasks ☐ Assign tasks to team members
  • Complete Quarterly Compliance Report due in 3 months
    ☐ Gather compliance data ☐ Prepare report ☐ Submit report

High Impact, Long-Term

  • Prepare for upcoming audit due in 2 months
    ☐ Review previous audit reports ☐ Address noted deficiencies ☐ Prepare necessary documentation
  • Develop Regulatory Compliance Training Program due in 3 months
    ☐ Create training materials ☐ Schedule training sessions ☐ Conduct training
  • Update Compliance Policies due in 6 months
    ☐ Review existing policies ☐ Update policies based on regulatory changes ☐ Distribute updated policies
  • Conduct Annual Product Review due in 1 year
    ☐ Collect product data ☐ Analyze data for compliance issues ☐ Implement corrective actions

Low Impact, Immediate

  • Review and Update Product Labels due in 2 weeks
    ☐ Review product labels for compliance ☐ Make necessary changes ☐ Print new labels
  • Ensure Proper Device Classification due in 2 months
    ☐ Review device classifications ☐ Reclassify devices if necessary ☐ Update relevant documentation