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If you are involved in planning, conducting or documenting performance evaluation and clinical performance studies for IVD devices in Europe, this intensive one-day course will enable a greater understanding of performance evaluation for In Vitro Diagnostic devices under the IVD Regulation, how performance fits into the product development lifecycle and IVD Regulation (IVDR) requirements for clinical evidence.
Please note: The training is in English.
This course will help you:
Successful completion of this training course by passing the examination and skills assessment, will demonstrate knowledge and basic skills to undertake and lead a management systems audit.
Upon completion of this training, delegates will be able to:
QA/Regulatory and R and D scientists involved in planning, conducting or documenting performance evaluation and clinical performance studies for IVD devices in Europe.
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