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Certification of Class D devices present additional challenges for manufacturer's due to the additional requirements for these high-risk devices.
The challenges are further complicated because the infrastructure required in the IVDR is not fully in place. While notified bodies are moving forward with certification of these devices, the path forward and current state of play can be confusing. The targets seem to be constantly changing, making it difficult to prepare for certification of these devices.
In this Live! show we discuss:
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