If you want to know what’s on our minds or get inspired …
ISO 14971:2019 Identifying potential use errors When working with usability engineering and interface design, a
Will a medical device break apart when dropped onto a concrete floor? Does the device remain safe and functional if stored for years on a shelf before reaching the patient?
The basic idea of DoE is that a number of factors, thought to impact a number of outputs, are systematically varied at different levels.
ISO 14971:2019 The highlights of the updated risk management standard Terminology update, most noticeably the