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 may become much more prominent in modern medical as it has potential to be…   Read more»

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 prospective, misclassifying a medical device within the wrong section can be detrimental. The…   Read more»

Intended use and the technological features of a device is usually the focus when determining which regulations apply to a product. Small distinctions in the function of a medical device can solidify which category the medical device would fall into….   Read more»

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 and has stayed as a reliable tool for clinicians. Electronic stethoscopes have entered the market,…   Read more»

Traceability and adaptability requires a systemic change control process in order to maintain efficiency. One example of this would be features embedded within digital project management tools. A traceability matrix which is updated based on a version-controlled requirements document could…   Read more»