I would take below steps if the customer requests changes to the project scope after the execution has started.   Understand the change in detail and document the request formally, including specific modifications, reasons, and urgency. Conduct an impact analysis…   Read more»

An organization can follow below methodologies to strike the right balance between maintaining control and allowing flexibility for creative problem-solving and adaptation. 1.Define Clear Guidelines, and define scope for Creativity: Establishing a clear goal helps to understand the problem at…   Read more»

A great way to capture lessons learned is by surveying the people working on and observing the project. One benefit of a mid project survey is that you can identify and correct issues before they become a real problem A…   Read more»

There are many effective strategies present in fostering team development during execution. Establishing team culture can help in team development. Team culture is a set of shared attitudes, values, goals, and practices that characterizes an institution or organization. Company culture…   Read more»

The right balance must be found between early engagement, management of expectations, and stakeholder fatigue. The engagement path should be proportional to stakeholders’ understanding of the project, the project’s impact, and the phase of development. Most of the stakeholder engagement…   Read more»

Apart from quality assurance we need quality Control (QC) in medical device development. It focuses on identifying defects in the final products or during production to ensure that only high-quality products are released to the market. These processes involve inspecting…   Read more»

In my opinion both Bone Fix and Facto set should have a formal joint steering committee. This committee can help take major decisions and also monitor the work progress closely. The committee can take decisions on any failures or change…   Read more»

Strategies to align stakeholders are, 1) Identify Your Stakeholders Before you can align your stakeholders, you first have to know who your stakeholders are. Stakeholder identification requires you to consider all the people, groups, and organizations that may be impacted…   Read more»

Project managers can strike the right balance between structured planning and adaptability by implementing agile principles within a structured framework.  This can be achieved in following ways, 1)Define clear goals and scope- Flexibility does not mean that you can change…   Read more»

I think Quality risk would be the most present in a project. I strongly believe quality risk is the most devastating risk. After all the planning and project management, if we manufacture a product of poor quality, it will not…   Read more»

Below are the parameters to determine the right level of WBS. 1.Project Complexity For simple straightforward projects, a high level WBS is needed. In complex projects more complicated and detailed WBS is necessary. 2. Size of the Team For small…   Read more»

Accurate estimation requires a combination of historical data, expert judgment, and quantitative tools. In project management, accurately estimating activity durations is a cornerstone of planning and execution. It serves as the basis for resource allocation, cost management, and timeline adherence,…   Read more»

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 overall residual risk should be considered acceptable. This is really a question of whether your product…   Read more»

Yes Organizational culture and resources have a deep impact on project execution. A strong culture shapes an organization’s decision patterns, guides actions, and drives individual behavior of all members. Project leaders who lack cultural awareness can become restricted and handicapped…   Read more»

To balance between rigorous design controls and innovation, companies can leverage robust documentation systems that can help to manage critical decisions and get a leeway for development by risk management. The engineers need to prioritize areas for innovation but in…   Read more»

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 a high-level foundation, capturing user needs, regulatory requirements, and functional expectations. The DSD…   Read more»

Yes, before recommending design modifications, additional testing should be performed to validate the root cause of the verification failure. This helps ensure that any design changes are based on data rather than assumptions. Recommended Steps: Conduct Root Cause Analysis Use…   Read more»

The probability of having to change the budget for additional experiments during a verification test depends on several factors, 1) Strict protocols: If the design has to meet strict parameters, variation in input and output can cause repeating the process….   Read more»

Yes, the prime concern in Human Device Exemption is Reasonable assurance of safety and Probable Benefits. The other problems are, 1) Safety and Risk-Benefit Evaluation -The manufacturer must provide sufficient data to demonstrate that the device does not pose an…   Read more»

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 records showing that the design was developed in accordance with planned design controls, ensuring compliance…   Read more»