Traceability and adaptability requires a systemic change control process in order to maintain efficiency. One example of this would be features embedd...

One product that comes to mind when discussing product life cycles is the stethoscope. The acoustic stethoscope has been used since at least the 1850s...

Intended use and the technological features of a device is usually the focus when determining which regulations apply to a product. Small distinctions...

Hurdles may not be the right term to use when accidently classifying a device as a Class III instead of a Class II. From a project management prospect...

Regulatory agencies should feel the need to adapt faster to keep up with the innovation happening in the medical device field. As it was mentioned, AI...

@ms3548 Underestimating regulatory requirements is indeed a common pitfall that does not get enough attention in my view. Implementing steps for early...

An essential strategy for avoiding scope creep and delivering a successful project is developing a dynamic risk management strategy. Dynamic risk mana...