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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.htmTABLE 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)