Activity

  • hc255 replied to the topic Design Change Request in the forum Project Management Process and Medical Device Development 7 years, 3 months ago

    At Getinge, the engineers redline the latest version of the document depending on what changes need to be incorporated which can be given by various inputs of managers, personnel etc. From there, the engineer creates a change notice which contains the necessary approvers, attachments, and documents affected. The approvers attached to the change notice are those that need to approve of the change since it is within their scope. The change notice is submitted on PTC Windchill which goes to Document Services. Doc Services reviews the CN to check for any errors regarding the CN itself, attachments, approvers, documents, etc. The CN then gets routed to the approvers to approve. Any concerns that come up, the creator of the CN would have to pullback the CN address the changes and reroute. If not, the CN goes into a final review then the changes are implemented. Finally, all those who have to that document in their curriculum are trained to the new revision of the document.