Clinical Procedure
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)…
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SYS-009 Clinical Procedure
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