No. If you purchased IEC 62304:2006 (base) before 2015, you are missing Amendment 1. You must purchase the consolidated version (CSV) or the amendment separately.
The standard (Clause 8) requires a software maintenance plan. Many engineers own the PDF but skip reading this section. Auditors will check if you have a bug-fix and patch deployment process. iec 62304 latest version pdf
This article is for informational purposes only and does not constitute legal or regulatory advice. Always consult with a qualified regulatory consultant and purchase official standards from the IEC or your local standards body. iec 62304 latest version pdf
: Standards evolve to address new technologies and safety concerns. Always verify that you're working with the latest version. iec 62304 latest version pdf
Depending on your country: