Clinical Procedure – Investigations, not Evaluations

This clinical procedure explains the basics of clinical investigations, but if you are looking for a CER procedure you want SYS-041 instead.

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Clinical Procedure (SYS-009)

Purpose – The purpose of this (13)-page procedure is to define the process for managing clinical studies and post-market clinical follow-up (PMCF) studies.

Scope – This procedure provides an overview of managing clinical studies for medical devices. This is the primary document meeting the applicable regulatory requirements for Clinical Studies and PMCF Studies as defined in your company’s Quality System Manual (POL-001)…

This procedure is meant to be a high-level procedure for companies that are outsourcing clinical investigations to a Clinical Research Organization (CRO). If your company intends to hire a Clinical Research Coordinator (CRC) and Clinical Research Associate (CRA), then you will need to create work instructions for site selection, site training, site monitoring, patient recruitment, etc.

Clinical Procedure Clinical Procedure   Investigations, not Evaluations

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. 

Clinical Procedure Clinical Procedure   Investigations, not Evaluations
SYS-009 - Clinical Procedure
SYS-009 Clinical Procedure
Price: $299.00

If you would like to learn more about clinical studies, please watch our webinar on clinical study basics with Jan Dugas.

 To view all available procedures click here

To review a sample Medical Device Academy procedure click below:

managment review sample SOP Clinical Procedure   Investigations, not Evaluations

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