FDA prioritizes an A-list and B-list for the guidance documents it plans to publish in FY 2017.
To truly understand device use scenario, one must observe with intention.
The unpredictability of the process can make it difficult to stay on track throughout every phase.
The agency addresses design and manufacturing considerations, along with device submissions for product approval.
A look at some common mistakes medical device companies make when approaching risk.
The comprehensive approach to human factors considers how a product operates alone, interoperability in larger settings, and data management.
Developing next-generation technology for medical devices is only half the battle when it comes to being first to market in today’s fast-paced global environment.
Telling the parent their child has a temperature of 38.674 °C may be an impressive engineering feat, but the last two digits have no real value and any time spent in development getting there was misspent.
Defiant minds can conceptualize embodiment that customers actually want. But determining methods to best define what the customer wants with novel technologies can be challenging as many of the methods published just don’t fit early stage work. How can we then manage the process of quality function deployment?
Whether you are designing an autonomous surgical robot, a patient-specific knee implant, or a paperweight for all the new regulations, volumes of data are useless without the proper specification framework to filter and process it.