We have developed a Medical Device Risk Management Procedure and Template in line with MDR and IVDR. The purpose of this risk management file template and procedure is to establish a standardized approach for identifying, evaluating, and controlling risks associated with medical devices. Provide a template for organizing and documenting risk management information. By implementing a comprehensive risk management file template and procedure, medical device manufacturers can ensure systematic and effective risk management practices, thereby enhancing the safety and reliability of their products.
Price: $1450 $1160 (20% off)
Yes these templates are made as per current requirement.
These procedures and templates include all necessary requirements of ISO 14971. By buying these templates you can have ready to use files and save your time from searching and editing , with help of these files you can submit your report efficiently.
These templates consist of a basic framework as per the requirements of ISO 14971 where the user can use it as a comprehensive repository of identified risks, their potential impacts, the control measures and mitigation strategies.