Other than updating the DHF as the project progresses, implementing a traceability matrix is another strategy to ensure that the DHF remains well-organized. A traceability matrix visual shows a clear connection between inputs, outputs, verification, and validation. That way during…   Read more»

Some responses already demonstrate how extensively a product that must meet Class III requirements can deter big companies from pursuing new medical treatment methods. However, the FDA does have a program called the “Breakthrough Devices Program,” which was created in…   Read more»

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 internal team with an intricate understanding of the product and its development that…   Read more»

Everyone has mentioned that early involvement with the FDA is important to ensure there are no conflicts and delays when approving the distribution of a product. It’s also important for companies to ensure that they get their working product to…   Read more»

As mentioned in this forum already, project managers have to perform risk management preparing them for cases such as this. Besides diversifying their suppliers, project managers can also have a main supplier that they meet with regularly and discuss any issues…   Read more»

@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 time to implement the technology anyway, depending on its simplicity. The same…   Read more»