What is IEC 62304?
This is the international standard produced by the International Electrotechnical Commission for Medical device software - Software life-cycle processes. It is currently in the 2006 date revision with a 2015 Amendment that has a stability date through 2025 and a possible 2nd edition release in 2022.
(IEC 62304:2006 + IEC 62304:2006/A1:2015)
This video will explain what this standard is, what it applies to and some of the activities for compliance. By the end you should be able to answer the question "What is IEC 62304?".
If you need assistance auditing your quality system to IEC 62304:2006 + IEC 62304:2006/A1:2015 or with developing a Software Safety Classification Rationale please visit us at our website or contact Robert Packard or Matthew Walker directly-
www.medicaldeviceacademy.com
Robert Packard- Rob@13485cert.com
