Conformity report of the medical electrical
device according to IEC EN 60601-1
Edition 3.1 of IEC 60601-1 for medical electrical equipment brings with it more than 400 pages of requirements and over 1500 applicability tests. With BAYOOSOFT Risk Manager you can efficiently design the process up to the conformity report – and accelerate it by up to 62%.
Through intelligent queries, the BAYOOSOFT Risk Manager filters out test questions that are not applicable to your medical device and answers them automatically. This provides you with interactive guidance through the standardisation process.
The full integration of the risk management process makes it quick and easy to link your existing assessments and analyses.
The Risk Manager’s intelligent guidance through the process to the conformity report completely eliminates duplicate data.
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