Medical Device Risk Management ISO 14971 checklist

This comprehensive medical device risk management ISO 14971:2019+A11:2021 checklist allows you to identify which clauses are applicable to your medical device(s) and input the reasonings behind your decision. It also allows you to input which evidences you have to prove that each clause has been fulfilled. 

This template should give you a clear overarching view to quicky identify that you are meeting the requirements of risk management for medical devices within your risk management file and medical device technical documentation. 

If you would like further information on our wide range of templates or have any suggestions for improvement that require support in addition to our templates in the form of other Medical Device Quality Assurance or Regulatory Affairs services, contact us at qmsregs@patientguard.com.