March 12, 2021
12:00 - 1:00 PM EST
As Europe transitions to the MDR/IVDR and Asia Pacific Regulators (including Australia’s TGA) focus more on clinical evidence, creating a Clinical Evaluation Report (CER) that meets international regulators’ expectations is becoming increasingly complex. Mr. Jimenez will review MEDDEV 2.7/1 Rev 4 requirements with an emphasis on strategies to meet individual requirements of specific regulators in one document. Key guidance’s on navigating the world of Clinical Evaluation Report and the MEDDEV 2.7/1 revision 4 guidance will be shared. This topic will also cover areas of focus for manufacturers and sponsors, based on recent feedback from European Notified Bodies and TGA reviews.
Register in advance for this meeting: https://upstate.zoom.us/meeting/register/tJYpcuCgrzMuGNFRKMalYH-tPKWeEMI1g8tw
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