As technology improves, this presents new complexities and hazards to the system. Therefore, medical electrical equipment must be compliant with applicable standards to protect individuals within medical facilities from potential electrical harm.
An insufficient or incomplete design input specification (DIS) can lead to a host of problems and create a big mess. A design input specification is a design control requirement for medical devices seeking regulatory approval. According to the FDA, your DIS must be testable, measurable, unambiguous, and traceable. Ambiguity leads to poor design inputs. … Continue reading “Your Design Input Specification is important beyond regulatory compliance”
https://youtu.be/OS2unSk68KQ The Manufacturer and User Facility Device Experience, or MAUDE, database is a tool that I use to help discover potential hazards when developing design input specifications for medical devices. It's very useful and I highly recommend this resource. Here is a simple guide I made to get your search started. … Continue reading Video | FDA’s MAUDE database: A medical device expert’s insight