As @mb698 have mentioned, every phase is important in project management however, initiating the project, planning on how to divide into segments and executing that plan is the most crucial part of a ...

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 precisely making sure that the device, equipment or...

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 helps you to produce an intended result in any proj...

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 to inform the project manager of their possible ho...

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 schedule is a way to account for unknown changes in th...

According to me, every milestone is important for any project. Therefore, any missed milestone will have an impact on a project. The only difference is whether the missed milestone falls under either ...

Design input document states what the product objective and its purpose. Besides the marketing team compiling the document, the whole team, sponsor, and customers also give their input, since the Desi...

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 manager must hold team minute meetings which provides...

As you have mentioned already, combination products are combined drugs, devices, and/or biological products with one another, and are a growing and important category of therapeutic and diagnostic pro...

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 successful project, it requires a sponsor, whose project t...

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 market or FDA database. If the FDA finds the devices...

Design Reviews are designed to be checkpoints during medical device product development to ensure the product design is safe, effective, and progressing. In order to have a proper meeting for the desi...

The core of the successful project manager revolved around the interactions of the team and their communications. As a project manager, one needs to communicate with everyone from a team member, to di...

I believe in order to use an unapproved device, Physician's must understand their role and responsibilities. And also understand when an emergency is to use an unapproved device. For a situation to be...

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. Sometimes a company discovers a problem and recalls a pro...