SOCRA 2021 NYS Chapter Virtual Series: Asia Pacific and European (MDR & IVDR) Clinical Evaluation Reports and Latest Requirements for Post Market Reporting

March 12, 2021
12:00 - 1:00 PM EST

SOCRA 2021 NYS Chapter Virtual Series:
Asia Pacific and European (MDR & IVDR) Clinical Evaluation Reports and Latest Requirements for Post Market Reporting
Luis Jimenez, MBA, Vice President of Business Development, Brandwood CKC
March 12, 2021, 12:00 - 1:00 p.m. 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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