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County Durham Practice Framework: Single Assessment Procedure & Practice Guidance April 2014 Contents Page No 1.0 Introduction 1 2.0 The 0-19 Integrated Children s Services Pathway 3 3.0 The Single
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What is single assessment procedure?
Single Assessment Procedure (SAP) is a standardized process used by authorities to evaluate and approve medical devices for market access in the European Union.
Who is required to file single assessment procedure?
Manufacturers of medical devices who wish to sell their products in the European Union are required to file the Single Assessment Procedure.
How to fill out single assessment procedure?
The Single Assessment Procedure is typically filled out by the manufacturer of the medical device, following the guidelines provided by the European authorities.
What is the purpose of single assessment procedure?
The purpose of the Single Assessment Procedure is to ensure that medical devices meet the necessary safety and performance requirements for market access in the European Union.
What information must be reported on single assessment procedure?
The Single Assessment Procedure typically requires information on the design, manufacturing process, intended use, and performance of the medical device.
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