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...

When new technologies emerge during a project, the manager must assess the impact and outcome carefully. The risks and benefits are weighed before pro...

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, ...