Last seen: Apr 16, 2025
WBS as your project’s blueprint–it breaks everything down into manageable chunks, making it easier to plan, organize, and control every aspect of your...
Accurate estimation requires a combination of historical data, expert judgment, and quantitative tools. In project management, accurately estimating a...
We can determine the risks which are worth taking by evaluating the residual risk evaluation. Ask yourself on a high level whether the product’s overa...
Yes Organizational culture and resources have a deep impact on project execution. A strong culture shapes an organization's decision patterns, guides ...
To balance between rigorous design controls and innovation, companies can leverage robust documentation systems that can help to manage critical decis...
Below are the reasons or purpose not to combine two documents ( DID and DSD ) to make a single document. 1)Progressive Detailing: The DID serves as...
Yes, before recommending design modifications, additional testing should be performed to validate the root cause of the verification failure. This hel...
The probability of having to change the budget for additional experiments during a verification test depends on several factors, 1) Strict protocols...
Yes, the prime concern in Human Device Exemption is Reasonable assurance of safety and Probable Benefits. The other problems are, 1) Safety and Risk-B...
The design history file is an important part of medical device development. The FDA has certain rules for this file first, the DHF must include record...
Organizations can balance innovations and compliance by following a structured approach. They should focus on the high-risk areas. Focus on the most i...
I think project managers can handle conflicts by various strategies. 1) Setting up a hierarchy, so that teammates don't get confused in their roles....
Yes, common practice can sometimes limit the creation and innovation of better medical products for several reasons: 1)Premarket Approval (PMA) must...
The most significant regulatory challenge in developing emerging medical technologies is balancing innovation with patient safety and user acceptance....
The manager can have various problems due to delayed supplies, damage during transport, and other factors. The issues can be dealt with tactically. Fi...