Not Notification to Notified Body Started Re-distribute DoC where applicable Not - Distributors Started - AR Not Inform distributors of new address of AR Started Marketing Not Review website for references to the AR Started Update labeling or DoCs may be uploaded to Not the website Started Not Revise marketing materials if AR address is included Started Management Representative Add discussion of this quality plan to the Management Review Meeting Quality Inform Notified Body, if relevant Not Started (Emergo has a template for this) Obtain updated EC certificates from NB if AR Not address is listed Started Update all QMS procedures where the AR address Not is listed (e.g. Vigilance, Technical File, etc.) Started Not Include quality plan in QMS Started Accounting Not Update address in system for billing Started Manufacturing Not Assess IFU and label stock Started
Notification to Notified Body Not Started Re-distribute DoC where applicable - Distributors - AR Not Started Inform distributors of new address of AR Not Started Marketing Review website for references to the AR Not Started Update labeling or DoCs may be uploaded to the website Not Started Revise marketing materials if AR address is included Not Started Management Representative Add discussion of this quality plan to the Management Review Meeting Quality Inform Notified Body, if relevant (Emergo has a template for this) Not Started Obtain updated EC certificates from NB if AR address is listed Not Started Update all QMS procedures where the AR address is listed (e.g. Vigilance, Technical File, etc.) Not Started Include quality plan in QMS Not Started Accounting Update address in system for billing Not Started Manufacturing Assess IFU and label stock Not Started