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September 2015

Software unit: specifying and testing according to IEC 62304

By Janos HackenbeckSeptember 15, 2015Leave a comment

The term software unit is defined in IEC 62304. Many manufacturers experience difficulties when specifying and testing these software units. This article gives you tips on how to avoid them.

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FDA MAUDE database: Input for risk management

By Christian RosenzweigSeptember 9, 2015Leave a comment

The FDA MAUDE database provides information on the “Manufacturer and User Facility Device Experience.” It thus corresponds roughly to the database used by the BfArM to publish manufacturer reports on risks.

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