Vigilance Reporting Procedure

Vigilance Reporting Vigilance Reporting ProcedureVigilance Reporting Procedure

Purpose – The purpose of this (5)-page procedure is to define your company’s requirements for vigilance reporting of adverse events associated with medical devices.

Scope – This procedure applies to medical devices distributed in the European Union. This procedure is the primary document meeting the applicable regulatory requirements for vigilance reporting for CE Marked products as defined in your company’s Quality System Manual (POL-001).

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Vigilance Reporting Vigilance Reporting Procedure
SYS-036 Vigilance Reporting Procedure
Price: $299.00
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managment review sample SOP Vigilance Reporting Procedure

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