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).

 Please note: This product will be delivered to the email address provided in the shopping cart transaction. After the transaction is verified, please check your email for the download. 

Vigilance Reporting Vigilance Reporting Procedure
Vigilance Reporting Procedure
Price: $299.00

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 To view all available procedures click here

To review a sample Medical Device Academy procedure click below:

 

managment review sample SOP Vigilance Reporting Procedure

 

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