Regulatory Compliance for Medical Product Development Template

Regulatory Compliance for Medical Product Development in Priority Matrix

Ensure regulatory compliance in medical product development, reducing risk and ensuring patient safety.

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Proposed Tasks

Critical and Immediate

• Identify Relevant Regulations due in 1 week
  ☐ Research regulations relevant to the product ☐ List down all identified regulations
• Create Compliance Task List due in 2 weeks
  ☐ List down all tasks required to comply with each regulation ☐ Assign each task to a responsible person
• Conduct Compliance Review due in 6 months
  ☐ Conduct a comprehensive review of all compliance activities ☐ Identify any areas for improvement
• Update Regulatory Information due in 6 months
  ☐ Review and update all regulatory information ☐ Ensure the team is aware of any changes
• Conduct Compliance Review due in 11 months
  ☐ Conduct a comprehensive review of all compliance activities ☐ Identify any areas for improvement
• Final Compliance Audit due in 1 year
  ☐ Conduct a final audit of all compliance tasks ☐ Ensure all tasks have been completed and all regulations have been complied with

Critical but not Immediate

• Train Team on Compliance Requirements due in 3 weeks
  ☐ Develop a training program for the team ☐ Conduct the training program
• Develop Compliance Monitoring System due in 1 month
  ☐ Identify key compliance indicators ☐ Develop a system for monitoring these indicators
• Update Compliance Monitoring System due in 5 months
  ☐ Update the compliance monitoring system based on feedback from the team ☐ Ensure the system is effectively tracking compliance
• Review Compliance Risks due in 7 months
  ☐ Review the compliance risk assessment ☐ Update the risk mitigation plan as necessary
• Update Compliance Monitoring System due in 10 months
  ☐ Update the compliance monitoring system based on feedback from the team ☐ Ensure the system is effectively tracking compliance

Not Critical but Immediate

• Review Regulatory Changes due in 1 month
  ☐ Set up a system for regularly reviewing regulatory changes ☐ Adjust compliance tasks as necessary based on these changes
• Review Compliance Task List due in 4 months
  ☐ Review the compliance task list ☐ Make necessary adjustments based on changes in regulations or product development
• Review Compliance Training Program due in 4 months
  ☐ Review the effectiveness of the compliance training program ☐ Make necessary adjustments to improve the program
• Review Compliance Training Program due in 9 months
  ☐ Review the effectiveness of the compliance training program ☐ Make necessary adjustments to improve the program
• Review Compliance Task List due in 12 months
  ☐ Review the compliance task list ☐ Make necessary adjustments based on changes in regulations or product development

Not Critical and not Immediate

• Audit Compliance Tasks due in 2 months
  ☐ Conduct a regular audit of all compliance tasks ☐ Identify any areas of non-compliance and address them
• Update Compliance Documentation due in 3 months
  ☐ Regularly update all compliance documentation ☐ Ensure all documentation is easily accessible to the team
• Assess Compliance Risks due in 3 months
  ☐ Conduct a risk assessment of non-compliance ☐ Develop a plan to mitigate these risks
• Update Compliance Documentation due in 8 months
  ☐ Update all compliance documentation ☐ Ensure all documentation is easily accessible to the team