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CE-Marking by Sibylle Scholtz, Stefan Menzl, Myriam Bec - Paperback NEW Sibylle
£66.74
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Located in: PR9 8QH SOUTHPORT UK, United Kingdom
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eBay item number:394717018758
Item specifics
- Condition
- Weight
- 413
- Subjects
- N/A
- Pages
- 344 Pages
- Size
- H:210mm, W:
- Topic
- Unknown
- Book Title
- CE-Marking by Sibylle Scholtz, Stefan Menzl, Myriam Becker (Pape
- ISBN
- 9783824918522
- Publication Year
- 2015
- Type
- Textbook
- Format
- Paperback
- Language
- English
- Publication Name
- Ce-Marking
- Item Height
- 210mm
- Publisher
- Tuv Media Gmbh/Tuv Rheinland
- Item Width
- 148mm
- Subject
- Engineering & Technology
- Item Weight
- 413g
- Number of Pages
- 344 Pages
About this product
Product Information
The development of medical technology in the last years of the 20th century has been very dynamic. Synthetic single-use products, artificial joint replacements, pacemaker technologies or minimal-invasive procedures result in a high standard of medical care. But despite of the huge progress in this field, we are presumably only at the beginning of a medical technology revolution. The 1st version of the German Medizinproduktegesetz (MPG, Medical Devices Act) came into effect on January 1, 1995. It represents the national implementation of the European directives 90/385/EEC for active implantable medical device, 93/42/EEC for medical devices and 98/79/EEC for in vitro diagnostic devices. With the implementation of this act in the EU internal market, the free movement of medical devices was established. Medical devices that are marketable in one member state of the EU are also marketable in the other EU countries. Manufacturers of medical devices can therefore place their products on the whole EU market. The CE-mark on the products is the proof of complying with the essential requirements. The Medical Devices Act guarantees the efficacy and safety of the medical device because the product has to undergo comprehensive control procedures during the design and manufacturing process. The CE-mark is a cachet for quality and efficacy. After the market access, the authorities take care of the safety for users and consumers via definition of essential requirements. This book presents the major aspects of the Medical Devices Act and the European directives. Moreover, the responsibilities and duties of a medical device manufacturer are explained as well as the product classifications and what the manufacturer has to keep in mind when designing and producing medical devices that comply with the legal requirements. A lot of physicians implant medical devices without being aware of the highly complex registration landscape. Especially in clinical research, the regulations regar
Product Identifiers
Publisher
Tuv Media Gmbh/Tuv Rheinland
ISBN-13
9783824918522
eBay Product ID (ePID)
14046538597
Product Key Features
Publication Name
Ce-Marking
Format
Paperback
Language
English
Subject
Engineering & Technology
Publication Year
2015
Type
Textbook
Number of Pages
344 Pages
Dimensions
Item Height
210mm
Item Width
148mm
Item Weight
413g
Additional Product Features
Item description from the seller
Business seller information
Charlies Chapters Ltd
Charles Sword
81 Balmoral Drive
SOUTHPORT
Merseyside
PR9 8QH
United Kingdom
krddf
Value added tax number:
- GB 920245361
Company registration number:
- 06386895
I certify that all my selling activities will comply with all EU laws and regulations.
CRN Number:
- 06386895
Seller assumes all responsibility for this listing.
eBay item number:394717018758
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Seller Feedback (350,152)
f***p (150)- Feedback left by buyer.
Past 6 months
Verified purchase
The book arrived well packed get & I pristine condition at a good price. I would have liked it by 1st class post & I contacted this Seller via EBAY 'CONTACT' but got NO RESPONSE via either my email account or on ebay and certainly not in my Spam folder...SO what can you say I was inconvenienced a bit but got a positive outcome? I think they're reliable for transactions but something is remiss with electronic communication via EBAY or perhaps not tech savvy or disinterested or unwell etc..
e***g (3085)- Feedback left by buyer.
Past 6 months
Verified purchase
As usual with this seller, the book was exactly as described and very well packed. However, delivery times can vary significantly. This was one of 4 books ordered at the same time. Two arrived in about a week, but this one took almost 3 weeks. A reliable seller who answers questions promptly, but could improve on dispatch times.
a***3 (5)- Feedback left by buyer.
Past month
Verified purchase
If you're happy to buy it now, receive it sometime in the future, this is the seller for you. Strangely nebulous and self destructive despatch times for a modern business, but, I've got my book, it was reasonably priced, packed okay and as described so a perfectly decent transaction. Happy enough customer, all fine.
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