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Mastering and Managing the FDA Maze: Medical Device Overview: A Training and Management Desk Reference for Manufacturers Regulated by the Food and Drug Administration
 
 
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Mastering and Managing the FDA Maze: Medical Device Overview: A Training and Management Desk Reference for Manufacturers Regulated by the Food and Drug Administration (Paperback)

~ (Author) "This chapter of Mastering and Managing the FDA Maze: Medical Device Overview Training and Management Desk Reference discusses FDA laws, regulations, and medical device oversight..." (more)
Key Phrases: master verification plan, requirements control matrix, international conformance standard, Discussion Required, Title Review Manager, Quality System Inspection Technique (more...)
3.0 out of 5 stars  See all reviews (1 customer review)
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Mastering and Managing the FDA Maze: Medical Device Overview: A Training and Management Desk Reference for Manufacturers Regulated by the Food and Drug Administration + The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices + Development of Fda-Regulated Medical Products: Prescription Drugs, Biologics, and Medical Devices
Price For All Three: $167.52

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Product Details

  • Paperback: 289 pages
  • Publisher: ASQ Quality Press (March 1999)
  • Language: English
  • ISBN-10: 0873894553
  • ISBN-13: 978-0873894555
  • Product Dimensions: 10.8 x 8.4 x 0.8 inches
  • Shipping Weight: 1.8 pounds (View shipping rates and policies)
  • Average Customer Review: 3.0 out of 5 stars  See all reviews (1 customer review)
  • Amazon.com Sales Rank: #256,823 in Books (See Bestsellers in Books)

    Popular in these categories: (What's this?)

    #11 in  Books > Science > Medicine > Special Topics > Prosthesis
    #43 in  Books > Professional & Technical > Law > Family & Health Law > Medical Law & Legislation
    #60 in  Books > Nonfiction > Law > Family & Health Law > Medical Law & Legislation

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More About the Author

Gordon Harnack
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Front Cover | Table of Contents | First Pages | Index | Back Cover | Surprise Me!
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Inside This Book (learn more)
First Sentence:
This chapter of Mastering and Managing the FDA Maze: Medical Device Overview Training and Management Desk Reference discusses FDA laws, regulations, and medical device oversight. Read the first page
Key Phrases - Statistically Improbable Phrases (SIPs): (learn more)
master verification plan, requirements control matrix, international conformance standard, device listing information, medical device oversight, document control matrix, adverse event report data elements, final acceptance checklist, approval cover sheet, design output specifications, design management oversight, significant additional study, device master record, premarket notification submission, medical device labeling, devices that fail, outpatient diagnostic facility, design history file, quality system role, inspectional strategy, verification test plans, management with executive responsibility, appropriate design controls, designated complaint unit, device history record
Key Phrases - Capitalized Phrases (CAPs): (learn more)
Discussion Required, Title Review Manager, Quality System Inspection Technique, United States, Cosmetic Act, Federal Food, Discussion Don't, Office of Operations, Effective Date Note, Modernization Act, Subpart A-General Provisions Sec, Warning Letters, Code of Federal Regulations, Definitions Device, Batch Number, Definitions Design, Discussion Design, Item Number, Office of Compliance, Public Health Service Act, Subpart L-Handling, Subpart N-Servicing, Final Team, Subpart H-Acceptance Activities
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Front Cover | Table of Contents | First Pages | Index | Back Cover | Surprise Me!
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Mastering and Managing the FDA Maze: Medical Device Overview: A Training and Management Desk Reference for Manufacturers Regulated by the Food and Drug Administration
73% buy the item featured on this page:
Mastering and Managing the FDA Maze: Medical Device Overview: A Training and Management Desk Reference for Manufacturers Regulated by the Food and Drug Administration 3.0 out of 5 stars (1)
$52.29
The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices, Second Edition
11% buy
The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices, Second Edition 4.5 out of 5 stars (2)
$100.00
Development of Fda-Regulated Medical Products: Prescription Drugs, Biologics, and Medical Devices
6% buy
Development of Fda-Regulated Medical Products: Prescription Drugs, Biologics, and Medical Devices
$55.00
The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices
5% buy
The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices 4.0 out of 5 stars (2)
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7 of 7 people found the following review helpful:
3.0 out of 5 stars OK, but I didn't "look inside this book", February 26, 2008
By Bruce_in_LA "reader_in_LA" (los angeles, ca United States) - See all my reviews
  
Use the "look inside this book" function to review the table of contents, etc. I thought the book would include some information on FDA device approvals but it does not. This book is about manufacturing, FDA product inspections, when the FDA reviews compliance documentation at your factory, etc. Just be sure that is what you need.
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