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”
“Why me?” —you may think. Overwhelmed and stressed out, you feel like the odds are stacked against you. You may feel anger. You may feel scared. Worst of all, you feel some embarrassment. You are bogged down.