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  • aaq2 replied to the topic What FDA Looks For In A Design Control System ? in the forum Introduction to Design Controls 7 years, 5 months ago

    Per the FDA site the regulation dos not prescribe the practices that must be used instead it establishes a framework that manufacturers must use when developing and implementing design controls.

    To add to what was posted by hv24, a sample table of contents could be found at the FDA link below:
    https://www.fda.gov/RegulatoryInformation/Guidances/ucm070627.htm

    TABLE OF CONTENTS
    • FOREWORD i
    • PREFACE iii
    • ACKNOWLEDGEMENT iv
    • TABLE OF CONTENTS v
    • INTRODUCTION
    • SECTION A. GENERAL
    • SECTION B. DESIGN AND DEVELOPMENT PLANNING
    • SECTION C. DESIGN INPUT
    • SECTION D. DESIGN OUTPUT
    • SECTION E. DESIGN REVIEW
    • SECTION F. DESIGN VERIFICATION
    • SECTION G. DESIGN VALIDATION
    • SECTION H. DESIGN TRANSFER
    • SECTION I. DESIGN CHANGES
    • SECTION J. DESIGN HISTORY FILE (DHF)