Complaint Handling for Medical Devices  

 

How do Quality Managers accelerate how they resolve complaints and FDA citations by collaborating effectively with design, engineering and regulatory submissions teams. 

 

 

You will discover the License to Cure solution on the 3DEXPERIENCE platform: the only end-to-end solution for medical device design, development, manufacturing, and lifecycle management. Our Technical Solution Specialist, Zain Mir, will illustrate how the License to Cure solution can manage complaints and non-conformance's that often trigger design changes and process changes depending on severity.  

 

Combined with regulatory document updates such as Design History File (DHFs), and DMRs Device Master Records (DMR), the License to Cure solution contains all the processes to accelerate complaint management from start to finish. 

 

You will learn how to: 

 

  1. Manage non-conformances and complaints with 100% traceability.  

  2. Issue and track Corrective And Preventive Actions (CAPA). 

  3. Establish traceability between complaint all the way to system requirements. 

  4. Govern the design change management process in sync with the CAPA process. 

  5. Quickly and automatically update DHF and DMR. 

  6. Make submission documents ready for review by simply dragging and dropping them to the right location.  

Zain Mir 

Technical Solution Specialist 

 

Shashänk Nanivadèkar  

Customer Success Enablement 

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