Direct Links to important GMP Medical Device Guidelines

DIRECTIVE 98/79/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 October 1998 on in vitro diagnostic medical devices

This Directive shall apply to in vitro diagnostic medical devices and their accessories. For the purposes of this Directive, accessories shall be treated as in vitro diagnostic medical devices in their own right. Both in vitro diagnostic medical devices and accessories shall hereinafter be termed devices.

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FDA Guidance for Industry - Cybersecurity for Networked Medical Devices Containing off-the-Shelf (OTS) Software

FDA Meinung zum Umgang mit "Bedrohungen" aus dem Netz bei vernetzten Medizinprodukten mit Standardsoftware

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FDA Guide to Inspections of Quality Systems

This document provides guidance to the FDA field staff on a new inspectional process that may be used to assess a medical device manufacturer’s compliance with the Quality System Regulation and related regulations.

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FDA Medical Device Tracking

This is a guideline regarding tracking of medical devices

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Guideline for the Monitoring of Clinical Investigations

The purpose of this guideline is to present acceptable approaches to monitoring clinical investigations

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FDA Labelling - Regulatory Requirments for Medical Devices

This document explains label and labelling regulations and requirements for medical devices

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FDA Medical Glove Guidance Manual

This document contains guidance on the basic regulatory requirements set forth in FDA’s regulations that all manufacturers and importers must consider when they plan to market medical gloves.

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Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices

This document is intended to provide guidance on the content of the STED for IVD medical devices to be assembled and submitted, where applicable, to a RA or CAB for premarket review, and for use post-market to assess continuing conformity to the Essential Principles.

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COMPUTERIZED SYSTEMS USED IN CLINICAL TRIALS

This document addresses issues pertaining to computerized systems used to create, modify, maintain, archive, retrieve, or transmit clinical data intended for submission to the Food and Drug Administration (FDA).

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FDA Guidance on Medical Device Patient Labeling; Final Guidance for Industry and FDA Reviewers

This guidance serves to assist manufacturers in their development, and to assist Center reviewers in their review and evaluation of medical device patient labeling to help make it understandable.

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GMP Conferences by Topics

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