Checklist – EU IVDD – Essential Principles (v.1.0)

Checklist – EU IVDD – Essential Principles (v.1.0)

$30.00

Checklist (Word template) for the Essential Principles (EP) under the Directive 98/79/EC (IVDD)

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Description

This document is a checklist (Word template) for the Essential Principles (EP) under the Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (IVDD).

Features

  • Fully implementable for a paper-based or a electronic Quality Management System (QMS)
  • Customisable without restrictions (parts highlighted in yellow help you to know where to customise the document)
  • Compliant with ISO 13485:2016
  • Tested and approved several times in EU medical devices companies

41 pages

Template version: 1.0

Customers purchasing the document will received the next versions for free.


Table of Content

A. General Requirements

B. Design and Manufacturing Requirements

  • Chemical and physical properties
  • Infection and microbial contamination
  • Manufacturing and environmental properties
  • Devices which are instruments or apparatus with a measuring function
  • Protection against radiation
  • Requirements for medical devices connected to or equipped with an energy source
  • Requirements for devices for self-testing
  • Information supplied by the manufacturer

Sample:

 

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