- Paperback: 128 pages
- Publisher: Paton Pr; Lslf edition (November 1997)
- Language: English
- ISBN-10: 096504453X
- ISBN-13: 978-0965044530
- Product Dimensions: 21.6 x 14.7 x 1 cm
- Shipping Weight: 204 g
- Amazon Bestsellers Rank: #1,564,165 in Books (See Top 100 in Books)
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Product Details |
Product Description
Book Description
If your organization manufactures and exports medical devices to the European Union, you need to know about the CE Mark and how the Medical Device Directive will affect your organization. The European Union's Medical Device Directive is one of the EU's most frustrating and difficult-to-decipher mandates. Fortunately, author Les Schnoll has taken the mystery out of the directive for medical device manufacturers. Schnoll walks readers through the directive's numerous classes, articles, annexes and requirements. This book is a must read if you're exporting medical devices to the European Union.
About the Author
Les Schnoll has more than 25 years' experience in quality assurance/quality control, auditing, regulatory compliance, management and microbiology in medical, pharmaceutical, clinical, industrial and food areas. He is knowledgeable in all aspects of medical device and material, pharmaceutical, food, clinical laboratory and chemical industry objectives. Schnoll is authorized by the Medical Device Agency in the United Kingdom to perform assessments to the Medical Device Directive and EN 46000 standards.
Inside This Book
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First Sentence
In 1985, the European Union implemented a new approach to developing standards for those products it considered critical from health and safety aspects. Read the first page
Front Cover | Copyright | Table of Contents | Excerpt | Index | Back Cover
In 1985, the European Union implemented a new approach to developing standards for those products it considered critical from health and safety aspects. Read the first page
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Front Cover | Copyright | Table of Contents | Excerpt | Index | Back Cover
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Most Helpful Customer Reviews on Amazon.com (beta)
Amazon.com:
3.0 out of 5 stars (1 customer review)
2 of 2 people found the following review helpful
3.0 out of 5 stars
Not so helpful, Aug 28 2005
By Thomas D. Kehoe - Published on Amazon.com
Amazon Verified Purchase(What's this?)
This review is from: Ce-Mark: The New European Legislation for Products : Electro-Technical Industry, Electrical Engineering and Machine Construction (Paperback)
This book mostly just reprints the CE regulations. It answered few of my questions, such as how to get a Product Certificate of Registration, etc.
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