Keeping the Design Input Document (DID) and Design Specification Document (DSD) separate helps ensure a smooth development process by allowing flexibility and better organization. The DID acts as a fo...

Great points! I also think that a hybrid approach could be a strong alternative that could maintain the clarity of separate documents while still improving efficiency. Instead of two entirely differen...

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, regu...

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 pro...

Avoiding PMA in medical device development can slow down innovation. Since PMA takes a long time and costs a lot, many companies choose to improve existing devices instead of creating entirely new one...

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...

One of the biggest challenges in project management is balancing the triple constraint—time, cost, and scope. In medical device development, each of these factors is crucial. For example, if a company...