Skip to content

Booksellers & Trade Customers: Sign up for online bulk buying at trade.atlanticbooks.com for wholesale discounts

Booksellers: Create Account on our B2B Portal for wholesale discounts

The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices by Amiram Daniel, Edward Kimmelman

The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices

by Amiram Daniel , Edward Kimmelman
Save 7% Save 7%
₹9,070.00
₹9,800.00
₹9,800.00
₹9,800.00
(-7%)
₹9,070.00
₹9,070.00

Imported Edition - Ships in 18-21 Days

Free Shipping in India on orders above Rs. 500

Request Bulk Quantity Quote
+91
Book cover type: Paperback
  • ISBN13: 9781636941417
  • Binding: Paperback
  • Subject: N/A
  • Publisher: ASQ Quality Press
  • Publisher Imprint: ASQ Quality Press
  • Publication Date:
  • Pages: 336
  • Original Price: USD 100.0
  • Language: English
  • Edition: N/A
  • Item Weight: 450 grams
  • BISAC Subject(s): Biotechnology

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 second edition 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. For each substantive requirement section there is: A verbatim statement of the QSReg requirement. A description of the comparable requirement in ISO 13485:2003, focusing on any additions to or differences from the requirements contained in the QSReg.Excerpts of the FDA responses to relevant comment groups contained in the Preamble to the QSReg. Excerpts from various FDA guidance documents related to quality management systems. A description of the relevant guidance contained in ISO/TR 14969:2004, focusing on any additions to or differences from the guidance in the Preamble and other FDA guidance documents, and, if useful, excerpts from relevant GHTF guidances. Authors' notes giving guidance derived from the authors' sixty years of regulatory compliance experience. 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.

Trusted for over 49 years

Family Owned Company

Secure Payment

All Major Credit Cards/Debit Cards/UPI & More Accepted

New & Authentic Products

India's Largest Distributor

Need Support?

Whatsapp Us

Related Category

medical > biotechnology

Bestselling

View All
Atomic Habits (Lead Title) by Clear, James

Atomic Habits (Lead Title)

Clear, James

₹585
₹899
₹899
₹899
(-35%)
₹585
₹585

• Author(s): Clear | James • Publisher: Penguin • Publisher Imprint: Penguin Random House • Subject: General Books

Diary of a Wimpy Kid: Partypooper (Book 20) by Jeff Kinney

Diary of a Wimpy Kid: Partypooper (Book 20)

Jeff Kinney

₹455
₹699
₹699
₹699
(-35%)
₹455
₹455

• Author(s): Jeff Kinney • Publisher: Penguin Random House Children's UK • Publisher Imprint: Penguin Random House Children's UK • BISAC: Comics & Graphic Novels - Humorous

Ikigai by Hector Garcia

Ikigai

Hector Garcia

₹390
₹599
₹599
₹599
(-35%)
₹390
₹390

• Author(s): Hector Garcia • Publisher: Penguin • Publisher Imprint: Penguin Random House • Subject: General Books

The Courage To Be Disliked How To Free Yourself Change Your Life And Achieve Real Happiness Courage To Series by Ichiro Kishimi

The Courage To Be Disliked How To Free Yourself Change Your Life And Achieve Real Happiness Courage To Series

Ichiro Kishimi

₹358
₹550
₹550
₹550
(-35%)
₹358
₹358

• Author(s): Ichiro Kishimi • Publisher: GROVE ATLANTIC • Publisher Imprint: Allen & Unwin • BISAC: Personal Growth - SuccessIchiro Kishimi lives in Kyoto. He writes, lectures and teaches in psychiatric clinics as a certified counsellor and c...

View full details
12 Years: My Messed-up Love Story by Chetan Bhagat

12 Years: My Messed-up Love Story

Chetan Bhagat

₹260
₹399
₹399
₹399
(-35%)
₹260
₹260

• Author(s): Chetan Bhagat • Publisher: HarperCollins Publishers India • Publisher Imprint: HarperCollins Publishers India • BISAC: GeneralFrom India's top-selling writer Chetan Bhagat comes a powerful new love story that will make you laugh, cry...

View full details
The Mountain Is You: Transforming Self-Sabotage Into Self-Mastery

The Mountain Is You: Transforming Self-Sabotage Into Self-Mastery

Brianna Wiest

₹260
₹399
₹399
₹399
(-35%)
₹260
₹260

• Author(s): Brianna Wiest • Publisher: Manjul Publishing • Publisher Imprint: Amaryllis • BISAC: Body Mind And SpiritThis is a book about self-sabotage. Why we do it, when we do it, and how to stop doing it—for good. Coexisting but conflicting n...

View full details
The Art of Spending Money: Simple Choices for a Richer Life by Morgan Housel

The Art of Spending Money: Simple Choices for a Richer Life

Morgan Housel

₹290
₹499
₹499
₹499
(-42%)
₹290
₹290

• Author(s): Morgan Housel • Publisher: Pan Macmillan • Publisher Imprint: Pan Macmillan • BISAC: Finance - Wealth ManagementA third book from the International bestselling author of The Psychology of Money and Same as Ever, lessons on harnessing...

View full details
Mother Mary Comes To Me by Arundhati Roy

Mother Mary Comes To Me

Arundhati Roy

₹585
₹899
₹899
₹899
(-35%)
₹585
₹585

• Author(s): Arundhati Roy• Publisher: PRH INDIA LOCAL PRINT• Publisher Imprint: Penguin Hamish Hamilton• BISAC: Literary FiguresArundhati Roy’s first work of memoir, this is a soaring account, both intimate and inspiring, of how the author became...

View full details
Truth without Apology: A Guide for Those Who Can Stand It by Acharya Prashant

Truth without Apology: A Guide for Those Who Can Stand It

Acharya Prashant

₹260
₹399
₹399
₹399
(-35%)
₹260
₹260

• Author(s): Acharya Prashant • Publisher: HarperCollins Publishers India • Publisher Imprint: HarperCollins Publishers India • BISAC: GeneralIn a world where vagueness is mistaken for depth and obscurity passes for wisdom, Truth without Apology ...

View full details
Grandma's Bag of Stories by Sudha Murthy

Grandma's Bag of Stories

Sudha Murthy

₹179
₹275
₹275
₹275
(-35%)
₹179
₹179

• Author(s): Sudha Murthy • Publisher: India Puffin • Publisher Imprint: India Puffin • BISAC: Short StoriesWho can resist a good story, especially when it's being told by Grandma? From her bag emerges tales of kings and cheats, monkeys and mic...

View full details
Days at the Morisaki Bookshop by Satoshi Yagisawa

Days at the Morisaki Bookshop

Satoshi Yagisawa

₹260
₹399
₹399
₹399
(-35%)
₹260
₹260

• Author(s): Satoshi Yagisawa • Publisher: Bonnier Books Ltd • Publisher Imprint: Bonnier Books Ltd

Deep Work: Rules For Focused Success In A Distracted World by Newport, Cal

Deep Work: Rules For Focused Success In A Distracted World

Newport, Cal

₹260
₹399
₹399
₹399
(-35%)
₹260
₹260

• Author(s): Newport, Cal • Publisher: Little, Brown Book Group • Publisher Imprint: Piatkus

Can We Be Strangers Again?: A National Bestseller by Shrijeet Shandilya

Can We Be Strangers Again?: A National Bestseller

Shrijeet Shandilya

₹195
₹299
₹299
₹299
(-35%)
₹195
₹195

• Author(s): Shrijeet Shandilya • Publisher: Ebury Press • Publisher Imprint: Ebury Press • BISAC: Romance - GeneralIn the electric haze of college life, three friends are bound by laughter, late-night talks and unspoken promises. But when two of...

View full details
The Secret of Secrets: (Robert Langdon Book 6) by Dan Brown

The Secret of Secrets: (Robert Langdon Book 6)

Dan Brown

₹975
₹1,499
₹1,499
₹1,499
(-35%)
₹975
₹975

• Author(s): Dan Brown • Publisher: Transworld Publishers Ltd • Publisher Imprint: Transworld Publishers Ltd • BISAC: Thrillers - EspionageDan Brown is the bestselling author of Digital Fortress, Deception Point, Angels and Demons, The Da Vinci C...

View full details
Magic of the Lost Temple by Sudha Murty

Magic of the Lost Temple

Sudha Murty

₹179
₹275
₹275
₹275
(-35%)
₹179
₹179

• Author(s): Sudha Murty • Publisher: India Puffin • Publisher Imprint: India Puffin • BISAC: Action & Adventure - General

Rich Dad Poor Dad: What the Rich Teach Their Kids about Money That the Poor and Middle Class Do Not!

Rich Dad Poor Dad: What the Rich Teach Their Kids about Money That the Poor and Middle Class Do Not!

₹390
₹599
₹599
₹599
(-35%)
₹390
₹390

• Publisher: Penguin • Publisher Imprint: Penguin Random House • Subject: General Books • BISAC: Personal Finance - GeneralApril of 2022 marks a 25-year milestone for the personal finance classic Rich Dad Poor Dad that still ranks as the #1 Pers...

View full details
World’S Greatest Books For Personal Growth & Wealth (Set Of 4 Books) : Perfect Motivational by Dale Carnegie, Napoleon Hill

World’S Greatest Books For Personal Growth & Wealth (Set Of 4 Books) : Perfect Motivational

Dale Carnegie, Napoleon Hill

₹390
₹599
₹599
₹599
(-35%)
₹390
₹390

• Author(s): Dale Carnegie | Napoleon Hill • Publisher: Fingerprint • Publisher Imprint: Fingerprint • Subject: General Books

The Housemaid: An Addictive Psychological Thriller With Mind-Bending Twists by Freida Mcfadden

The Housemaid: An Addictive Psychological Thriller With Mind-Bending Twists

Freida Mcfadden

₹358
₹550
₹550
₹550
(-35%)
₹358
₹358

• Author(s): Freida Mcfadden • Publisher: Penguin Select Print • Publisher Imprint: Penguin Select Publishing"Multi-Million Copy Bestselling Series •Now Being Made Into a Major Motion Picture Starring Sydney Sweeney and Amanda Seyfried #1 New Yor...

View full details
101 Tales: The Great Panchatantra Collection by Wonder House Books

101 Tales: The Great Panchatantra Collection

Wonder House Books

₹390
₹599
₹599
₹599
(-35%)
₹390
₹390

• Author(s): Wonder House Books • Publisher: Wonder House Books • Publisher Imprint: Wonder House Books • BISAC: Comics & Graphic Novels - Fairy Tales, Folklore, Legends & MTimeless Wisdom, Talking Animals & Life Lessons for Young Min...

View full details
Man's Search For Meaning by Viktor E. Frankl

Man's Search For Meaning

Viktor E. Frankl

₹260
₹399
₹399
₹399
(-35%)
₹260
₹260

• Author(s): Viktor E. Frankl • Publisher: Random House • Publisher Imprint: Random Hou • Subject: Medical, Nursing and Health Sciences

Bacchon KI Doctor's Desi Parenting Book: A Doctor-Mom's Guide to Milk, Myths, Motherhood and More by Madhavi Bharadwaj

Bacchon KI Doctor's Desi Parenting Book: A Doctor-Mom's Guide to Milk, Myths, Motherhood and More

Madhavi Bharadwaj

₹260
₹399
₹399
₹399
(-35%)
₹260
₹260

• Author(s): Madhavi Bharadwaj • Publisher: PRH India • Publisher Imprint: Penguin Ebury Press • BISAC: Parenting - MotherhoodWelcome to the wild, messy, wonderful world of parenting--where the nights are long, the diapers are explosive, and unso...

View full details
The Outsider by Vir Das

The Outsider

Vir Das

₹455
₹699
₹699
₹699
(-35%)
₹455
₹455

• Author(s): Vir Das • Publisher: HarperCollins Publishers India • Publisher Imprint: HarperCollins Publishers India • BISAC: Entertainment & Performing ArtsComedian and actor Vir Das is beloved (by some, tolerated by others, blocked by a few...

View full details
The Very Hungry Caterpillar by Eric Carle

The Very Hungry Caterpillar

Eric Carle

₹293
₹450
₹450
₹450
(-35%)
₹293
₹293

• Author(s): Eric Carle • Publisher: Penguin Books, Limited (UK) • Publisher Imprint: Penguin Books, Limited (UK) • BISAC: Animals - Butterflies, Moths & CaterpillarsEric Carle's The Very Hungry Caterpillar is a perennial favourite with child...

View full details
Too Good to Be True : A smart, funny will-they-won’t-they romance by mostlysane by Prajakta Koli

Too Good to Be True : A smart, funny will-they-won’t-they romance by mostlysane

Prajakta Koli

₹260
₹399
₹399
₹399
(-35%)
₹260
₹260

• Author(s): Prajakta Koli • Publisher: Harper Fiction India • Publisher Imprint: Harper Fiction India • BISAC: Romance - ContemporaryWinner of the Amazon India Popular Choice Debut Book 2025 Award. From one of India's most-loved creators comes s...

View full details
Home
Genres
Account
Chat