Design & Development

“Your Design Input Specification is important beyond regulatory compliance”

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”

Design & Development, Medical Device

How to turn User Needs into Design Specifications (with tables)

Creating your design input specification (DIS) should be the first stage of any product design process. It is a vital tool your Design Team will use as the framework for the design and development of your medical device, and to also comply with regulatory requirements. Wait! Just what is DIS? In the simplest terms, your… Continue reading How to turn User Needs into Design Specifications (with tables)