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For many organizations, the transition from IVDD to IVDR has proven to be challenging—particularly in the areas of technical documentation, clinical evidence, and risk management. For manufacturers of new devices, this is also highly important, as devices must comply with IVDR requirements before being placed on the market.

During the training we will open the content of the IEC 60601-1 series of standards in terms of technical requirements. We review IEC 60601-1 as part of its approvals for different markets. From IEC 60601-1 ed. 3.2, we provide you with an understanding of testing, electrical safety and risk management requirements for medical devices. All of which are key considerations in the design and testing of medical devices.