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Medical Device Project

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(@jo277)
Posts: 69
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Speaking from Nov. 2023, the specifications for Prof. Simon's final project have remained relatively the same. Currently, my team is still in the drafting phase, working to find resources and develop our own individual department assignments based on our team's plans and schedule. Currently, we aren't facing any challenges because it is still a developing progress but I would assume ensuring continuity and fluidity between all parties would be one of the obstacles that we would face.

 
Posted : 21/11/2023 5:16 pm
(@jh597)
Posts: 77
Trusted Member
 

My team has had two meetings so far virtually since it is difficult to meet in-person due to each person having different class schedules as well as working during the day. As of now, we have completed the DDP, a draft of the DID, and are working through completing the regulatory rationale first draft. Our group is following the structure that Dr. Simon has laid out and have developed a timeline for the documentation within our Gantt chart, in terms of when drafts should be completed and a review period for other team members to give feedback to the author of the document. Upon completing the regulatory rationale first draft, the marketing plan and the preclinical protocol will begin to be developed. The biggest challenge so far has been planning for deadlines around each person's schedule as most members are taking multiple other classes as well as working full-time, so communication has been key in ensuring that members will have enough time to complete a draft of the document.

 
Posted : 23/11/2023 1:07 pm
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