Medical device firms' obligation doesn't end upon obtaining a marketing clearance, approval, or certificates. Medical device manufacturers are required to report adverse events to the authorities (e.g., Competent Authorities, Health Canada and US FDA), where applicable.
To achieve compliance and to remain compliant with the adverse event reporting requirements, it is imperative that medical device manufacturers understand what requirements apply and how to meet the said requirements. This video will walk you through to help you understand the applicable adverse event reporting requirements and remain in conformity with the requirements in EU, Canada and US.
This video will help you profoundly change your way of planning, developing, implementing and following your relevant and applicable processes in a more efficient and effective manner.
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Organization: NetZealous BDA GlobalCompliancePanel
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Email: support@globalcompliancepanel.com
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Негізгі бет Medical Device Adverse Event Reporting in EU, US and Canada
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