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, varia...

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 s...

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 accorda...

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 ...

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 e...

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 rev...

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/...

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 agencie...

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 co...

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 ...