IEC 62366 Fast Track Amendment Proposal

A proposal has been made for a fast-track amendment to IEC 62366 related to use with legacy products. Application of “62366 Medical devices – Application of usability engineering to medical devices” to legacy devices has been inconsistent and problematic; this proposal is for a fast track amendment to address what is called User Interface of Unknown Provenance (UOUP). This proposal includes a draft for a section to address this, including review of field history and a simplified approach for addressing usability in terms of identification of frequently used and primary operating functions and a risk management review.

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
Partners located in the US (CA, FL, MA, MN) and Italy.