Direkt Links to important GMP Medical Device Guidelines

FDA ORA Inspectional References Guide to Inspectors of Quality Systems, August 1999

This FDA guideline addresses FDA inspectors for medical devices and gives hints as to how investigators can conduct inspections effectively and efficiently

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21 CFR Part 800 Medical Devices - General

This part of the US Code of Federal Regulations describes requirements for specific Medical Devices like Contact Lens Soutions.

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FDA Guide to Inspections of Electromagnetic Compatibility Aspects of Medical Device Quality Systems

This guide provides FDA investigators with information regarding electromagnetic compatibility (EMC) and how it is likely to be addressed in a medical device firm's Quality System/Good Manufacturing Practices (QS/GMP) (21 CFR Part 820).

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FDA Guide to Inspections of Medical Device Manufacturers (12/97)

Guide for FDA Investigators for the Investigation of Medical Device Manufacturers

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FDA Guide to Inspections of Foreign Medical Device Manufacturers (9/95)

This guide was prepared to address concerns about consistency and uniformity of inspetion between the domestic (US) and the foreign inspection programs.

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FDA Medical Device Reporting: An Overview

This document is intended to help manufacturers and user facilities understand the basic requirements for reporting adverse events involving medical devices as required by the Medical Device Reporting (MDR) Regulation (Title 21, Code of Federal Regulations, Part 803).

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FDA Guide to Inspections of Quality Systems (08/99)

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

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FDA DESIGN CONTROL GUIDANCE FOR MEDICAL DEVICE MANUFACTURERS

Guidance document which relates to FDA 21 CFR 820.30 and Sub-clause 4.4 of ISO 9001

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FDA Human Factors Implications of the New GMP Rule Overall Requirements of the New Quality System Regulation

Selected Portions of the Quality System Regulation that Apply to Human Factors

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FDA General Principles of Software Validation; Final Guidance for Industry and FDA Staff

Guideline for industry and FDA Staff for the validation of software regarding medical devices

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GMP Conferences by Topics

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