One way to mange time effectively when developing biomedical devices is to determine the critical path. This method involves identifying the longest sequence of dependent tasks that needs to be comple...

The decision on the number of alternative vendors likely uses the same criteria used for solicitation planning. The evaluation criteria of price, understanding of need by seller, overall/life cycle co...

A WBS facilitates better project planning because it requires the project manager and other team members to have a clear understanding of what must be undertaken to reach the intended project goal. Es...

To ensure all elements of the project are properly coordinated among the 10 knowledge groups, planning meetings should be conducted to ensure every element is appropriately managed. Such meetings duri...

One strategy I think that could be implemented is tier-based data sharing. While working as an intern, I noted in Outlook there were sensitivity labels for emails: General, Public, Non-Business, Confi...

NDAs are ways to ensure a company’s confidential information about their product stays within their personnel and necessary external parties such as the FDA. As the previous user had stated, their use...

Typically in the medical device industry, avoidance, mitigation, and acceptance are used as risk management approaches. Transference is uncommon. If used, as others have stated before, insurance is us...

This week, we learned about what would need monitoring and controlling in a project such as the schedule, budget, resources, performance, and scope. For example, the schedule can change when a part do...

A majority of users defined success as the successful completion of the project; they focused more on the internal industry team’s perspective of success. From a business perspective, factors such as ...

Design validation checks if the product’s inputs are equal to the product’s user needs or intended use. This types of testing studies the product under its intended environment/conditions. However, it...

Information distribution is essential during the executing process. Being up to date regarding emails and voice messages helps project managers remain informed regarding the current status of the proj...

After reading through the replies to my original post (the topic starter), I noticed a trend in medical devices suggested by previous posts that is likely to have a late finish and early finish. As th...

I agree with a previous user that stated management of project scope is the most difficult part of a project. This previous user focused more on the scheduling and planning aspect of scope management....

The importance of strategic and business management proficiency in a project manager's skill set should not be undervalued. Having an understanding of the business context is important when working in...

One ISO standard I think would always be followed if ISO requirements did not exist is: ISO 10993, the standards for biocompatibility. This standard calls for evaluation of all data from materials, p...