@amm7 To add on to your potential test, it may be better to test if the label does better on a flat surface or a curved surface. If the testing is don...

@ms3548 Adding to your point, its important to have the project teams and stakeholder have multiple ways to determine how to stay in scope with the pr...

One thing that may help when considering changing test parameters or even mitigating failures can be consulting experts in fields that deal with the p...

@pd493 To add upon your bringing up focusing on high-risk areas, rather than just focusing on one area at a time, they can split up the product in par...

All the methods listed in this forum are great ways to have flexibility on a DDP, however implementing risk strategies, such as a Risk Register. In a ...

Other than updating the DHF as the project progresses, implementing a traceability matrix is another strategy to ensure that the DHF remains well-orga...

Some responses already demonstrate how extensively a product that must meet Class III requirements can deter big companies from pursuing new medical t...

A mix of both would probably be the most advantageous for medical device companies. You would get the best of both worlds: on the one hand, an interna...

Everyone has mentioned that early involvement with the FDA is important to ensure there are no conflicts and delays when approving the distribution of...

As mentioned in this forum already, project managers have to perform risk management preparing them for cases such as this. Besides diversifying their...

@sn64 The length of the project should also be considered, no? If a project's lifetime is from a week to a few months, there probably wouldn't be any ...