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
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)
A design input specification (DIS) plays a critical role in any product design process. The product DIS contains all the characteristics of a device that are used as a basis for product design. The level of detail that your design inputs cover can be the deciding factor that makes or breaks a smooth run to… Continue reading KICKSTART YOUR DIS: 6 Approaches to Generate Design Inputs