FDA and Worldwide Quality System Requirements Guidebook for Medical Devices

This new and expanded Second Edition maintains the organizational approach of the first and includes the requirements and guidance contained in the Quality System Regulation (QSReg), the ISO 13485:2003 standard, the ISO/TR 14969:2004 guidance document, and, as appropriate, a number of the FDA and Global Harmonization Task Force (GHTF) guidance documents. This book also addresses a number of additional topics, such as the incorporation of risk management into the medical device organization’s QMS, QMS issues related to combination products, the key process interactions within a QMS, effective presentation of and advocacy for a QMS during FDA inspections and third-party assessments, and future FDA compliance and standards activities. The organization of the guidebook is based on the order of the requirements in the QSReg. This guidance book is meant as a resource to manufacturers of medical devices, providing up-to-date information concerning required and recommended quality system practices. It should be used as a companion to the regulations/standards themselves and texts on the specific processes and activities contained within the QMS. Content:• Front Matter • Introduction • An At-a-Glance Comparison of the 1996 QSReg and ISO 13485:2003 • Table of Contents •Part I. Detailed Analysis of the Requirements and Guidances Subpart A. General Provisions Subpart B. Quality System Requirements Subpart C. Design Controls Subpart D. Document Controls Subpart E. Purchasing Controls Subpart F. Identification and Traceability Subpart G. Production and Process Controls Subpart H. Acceptance Activities Subpart I. Nonconforming Product Subpart J. Corrective and Preventive Action Subpart K. Labeling and Packaging Control Subpart L. Handling, Storage, Distribution, and Installation Subpart M. Records Subpart N. Servicing Subpart O. Statistical Techniques •Part II. Additional Subjects Risk Management • Combination Products • Process Interactions within the QMS How to Present and Advocate for Your QMS during Inspections and Assessments • Future FDA Compliance Activities and Use of Standards Index

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