Declaration of Conformity (API Server)
EU DECLARATION OF CONFORMITY
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Unique identification of the product
The Royal College of Paediatrics and Child Health Digital Growth Charts Application Programming Interface Server, all versions. https://github.com/rcpch/digital-growth-charts-server
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Name and address of the manufacturer or his authorised representative
The Royal College of Paediatrics and Child Health (RCPCH), 5-11 Theobalds Road, London, WC1X 8SH (telephone: +44 (0)20 7092 6000).
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This declaration of conformity is issued under the sole responsibility of the manufacturer (or installer)
The Royal College of Paediatrics and Child Health (RCPCH)
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Object of the declaration (identification of product allowing traceability. It may include a colour image of sufficient clarity to enable the identification of the product, where appropriate.)
There is no image, this is an entirely software product, with no dedicated hardware.
Server application code is located at https://github.com/rcpch/digital-growth-charts-server
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The object of the declaration described in point 4 is in conformity with the relevant Union harmonisation legislation
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Regulation (EU) 2017/745 - Medical Devices
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References to the relevant harmonised standards used, or references to the specifications in relation to which conformity is declared
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Technical file
The complete unabridged technical file, all documentation, instructions for use, and the application source code itself are available publicly within this RCPCH dGC documentation site and the GitHub repository https://github.com/rcpch/digital-growth-charts-server.
Signed for and on behalf of | The Royal College of Paediatrics and Child Health |
Place of Issue | Cawood, North Yorkshire, UK |
Date of Issue | 7th May 2021 |
Name | Dr Marcus Baw |
Position | Lead Developer, Clinical Safety Officer, GP and EM Clinician. |
Signature |