Templates for ISO 13485, IEC 62304, ISO 14971 and ISO 62366 compliance. These are markdown files. If you prefer to download them as .docx, .pdf, and .html files, head over to our website at openregulatory.com/templates. Rationale Regulatory compliance is an opaque field, riddled with sub...
Usability standard IEC 62366-1:2015 + AMD 1:2020 Software standard IEC 62304:2006 + AMD1: 2015 Clause 8 updates allow IEC 62368-1:2018 compliant devices to provide means of operator protection. Why choose UL Solutions? Since the publication of the IEC versions of 60601-1 in late 2020, ou...