Asia Pacific and European (MDR & IVDR) Clinical Evaluation Reports and Latest Requirements for Post Market Reporting

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Presented By: SOCRA
Friday, March 12, 2021
12:00 pm – 1:00 pm

Location: 2021 NYS SOCRA Chapter Virtual Series

Presenter: Luis Jimenez, MBA, Vice President of Business Development, Brandwood CKC

Abstract: 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.

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