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Standard-compliant verification: Software for medical technology according to IEC 62304

Article by Frank Büchner in German.


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The IEC 62304 standard, a standard for medical device software harmonized in Europe, requires the verification of software units. Unlike other standards, such as ISO 26262 in the automotive sector, it is rather tight. This article provides an overview of the measures required to verify a software unit according to IEC 62304.


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