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»

Organizations can balance innovations and compliance by following a structured approach. They should focus on the high-risk areas. Focus on the most important safety and quality requirements to avoid unnecessary delays. Use step-by-step approval so that compliance and innovation move…   Read more»

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. Define roles, responsibilities, and project goals early on to reduce misunderstandings. 2 ) There should be…   Read more»

Yes, common practice can sometimes limit the creation and innovation of better medical products for several reasons: 1)Premarket Approval (PMA) must undergo rigorous clinical trials and regulatory reviews, which can take years and cost millions of dollars. This discourages companies…   Read more»

The most significant regulatory challenge in developing emerging medical technologies is balancing innovation with patient safety and user acceptance. FDA has evolved and has regulatory rules for  AI/ML-based software.1)As AI-based devices are constantly emerging, getting FDA approval every time for…   Read more»

The manager can have various problems due to delayed supplies, damage during transport, and other factors. The issues can be dealt with tactically. First, maintain a good rapport with delivery agencies. The manager should always rely on reliable agencies and…   Read more»

When new technologies emerge during a project, the manager must assess the impact and outcome carefully. The risks and benefits are weighed before proceeding with the technology. The manager should communicate with other project managers who have used the technology…   Read more»

If there is a failure the manager and team have to diagnose the problem whether it is the failed design verification test, the actual device failure, or both. A detailed analysis of failure should be done, to determine the problem…   Read more»