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Emmet Tobin ISO 13485 Starter Guide (Paperback) (UK IMPORT)
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Item specifics
- Condition
- Book Title
- Iso 13485 Starter Guide
- Publication Name
- ISO 13485 Starter Guide
- Title
- ISO 13485 Starter Guide
- Format
- Trade Paperback
- ISBN-10
- 1534675272
- EAN
- 9781534675278
- ISBN
- 9781534675278
- Publisher
- CreateSpace
- Genre
- Technology & Engineering
- Topic
- Biomedical
- Release Date
- 13/06/2016
- Release Year
- 2016
- Language
- English
- Item Height
- 0.2in
- Item Length
- 8in
- Item Width
- 5in
- Item Weight
- 5.3 Oz
- Publication Year
- 2016
- Number of Pages
- 86 Pages
About this product
Product Information
Revised in 2021, This short, concise book provides an introduction to ISO 13485. It is written in accessible language, providing a straight forward resource for the reader. It introduces the core themes of the standard to those who wish to work in regulated industries such as medical devices, highlighting key areas and practices. It is a perfect introduction for operators, factory workers, engineers and managers wishing to learn the fundamentals. It is also a useful pocket reference book, small enough to slip into a case or pocket. ISO 13485 is the Quality management standard of choice for manufactures of medical devices. Revised in 2016, ISO 13485:2016 "specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements." The scope of the standard can apply to any organization or company involved in throughout the life-cycle of a product, including design and/or development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of technical or professional services.(Page count pages 82) While not suitable for experienced or advanced professionals, this publication aims to provide context and a fundamental grounding in ISO 13486- Quality management system for medical devices. Second Edition, 2021
Product Identifiers
Publisher
CreateSpace
ISBN-10
1534675272
ISBN-13
9781534675278
eBay Product ID (ePID)
234498877
Product Key Features
Book Title
Iso 13485 Starter Guide
Format
Trade Paperback
Language
English
Topic
Biomedical
Publication Year
2016
Genre
Technology & Engineering
Number of Pages
86 Pages
Dimensions
Item Length
8in
Item Height
0.2in
Item Width
5in
Item Weight
5.3 Oz
Additional Product Features
Target Audience
Trade
Item description from the seller
Business seller information
Value Added Tax Number:
- GB 864 1548 11
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eBay item number:305365391815
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Product is 95% alike picture but a little more blurry. Controller play well but had a notice from psn that my joypad wasn't authentic and could by problematic🤷♂️ no trouble so far! Shipping was fast but no tracking and worst packaging ever.. like the box came banged up... send a question to seller never had a reply 😅.... Good product overall, excellent price, fast shipping, wrapped only on 4 sides out of 6, no tracking and never reply... 4★ product / 2★ seller ✌️
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The book is in perfect condition, brand new, and is exactly as described. This item is difficult to find here, and the seller priced it very reasonably. It shipped from the UK to Canada, and unfortunately took a little longer to arrive than the seller hoped, but it was shipped less than 24 hours after I purchased. When I contacted the seller, they were very responsive and helpful. I would not hesitate to purchase from this seller again. Definitely recommend!
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