Direct Links to important GMP Medical Device Guidelines

FDA Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices

This guidance document represents the agency’s current thinking on the documentation that should be provided in premarket submissions for medical devices using OTS software.

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FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

This document provides guidance on the regulatory review of premarket submissions for software contained in medical devices.

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Labelling For Medical Devices

The Guidance describes principles of labelling requirements for Medical Devices.

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Charge & Mission Statement

The purpose of the guidance is to improve the protection of the health and safety of patients, users and others by reducing the likelihood of the same type of adverse incident being repeated in different places at different times.

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Process Validation Guidance

This process validation guidance is intended to assist manufacturers in understanding quality system requirements concerning process validation.The guidance is revised due to the changes in ISO 13485:2003.

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Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers: General Requirements - Supplement No. 4 - Compilation of Audit Documentation (Clause 5.7)

This document has been written to provide assistance in the application of the 'Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers: General requirements’ and should be read in conjunction with that document.

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Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers –Part 1: General Requirements

This document provides guidelines for auditing organisations responsible for establishing, planning, carrying out and documenting audits of quality systems to address regulatory requirements for manufacturers of medical devices.

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Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers General Requirements Supplement No. 6 Observed Audits of Conformity Assessment Bodies

This document has been written to provide assistance in the application of the 'Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers: General requirements’ and should be read in conjunction with that document.

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21 CFR Part 26 Mutual recognition of pharmaceutical good manufacturing practice reports, and certain medical device product evaluation reports: US and the EC

Text of the Mutual Recognition Agreement, signed by the United States and the European Community in May, 1998. The proceedings are discontinued at the moment!

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DECISION No 1/2017 OF THE COMMITTEE ESTABLISHED UNDER THE AGREEMENT BETWEEN THE EUROPEAN COMMUNITY AND THE SWISS CONFEDERATION ON MUTUAL RECOGNITION IN RELATION TO CONFORMITY ASSESSMENT

amendment of Chapter 4 on medical devices, Chapter 6 on pressure vessels, Chapter 7 on radio equipment and elecommunication terminal equipment, Chapter 8 on equipment and protective systems intended for use in potentially explosive atmosphere, Chapter 9 on electrical equipment and electromagnetic compatibility, Chapter 11 on measuring instruments, Chapter 15 on medicinal products, GMP inspection and batch certification, Chapter 17 on lifts, and Chapter 20 on explosives for civil use, and the update of legal references listed in Annex 1 [2017/2118] THE COMMITTEE,

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GMP Conferences by Topics

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