IEC 82304-1: Health software Final Draft

A final draft for approval (FDIS) of “IEC 82304-1: Health software – Part 1: General requirements for product safety” has been circulated. The ballot ends on October 14, and the standard is expected to be published by the end of 2016. This standard applies to software products that do not require specific hardware designed for health use. The primary focus of this standard is on requirements for the developers of the software product. It is intended to be used alongside IEC 62304 and to cover aspects of the software product that are not covered in IEC 62304, such as accompanying documentation and software validation. This is for Health Software in general not just medical device software.

CSV Training Course

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

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.