As @mb698 have mentioned, every phase is important in project management however, initiating the project, planning on how to divide into segments and ...
Design Validation is a powerful tool to achieve a highly effective product. For medical devices, it is crucial to conduct a human factor study to be p...
According to me, logging at work has proven to be very effective and save the struggle when any issue occurs. For me, keeping a detailed log of work h...
For any project to succeed does not matter what field it is from, communication and collaboration is the key. It is every team members responsibility ...
In the field of project management, things do go wrong and unexpected changes are always there. So, including a time buffer as a line item in the sche...
According to me, every milestone is important for any project. Therefore, any missed milestone will have an impact on a project. The only difference i...
Design input document states what the product objective and its purpose. Besides the marketing team compiling the document, the whole team, sponsor, a...
According to me, to help track the status of the project, one must establish goals and milestone and in order to keep track of this milestone, the man...
As you have mentioned already, combination products are combined drugs, devices, and/or biological products with one another, and are a growing and im...
When it comes to an ideal project team, I believe the project manager must choose the project and its team members wisely. In order to have a successf...
In my opinion, I don't think it is necessary to have a separate classification for the device as the function of the device is already known in the ma...
Design Reviews are designed to be checkpoints during medical device product development to ensure the product design is safe, effective, and progressi...
The core of the successful project manager revolved around the interactions of the team and their communications. As a project manager, one needs to c...
I believe in order to use an unapproved device, Physician's must understand their role and responsibilities. And also understand when an emergency is ...
Once a product is in the market for the public to use, any unpredictable problems can lead to a recall. However, recalls are always voluntary. Sometim...