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.
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Book Description
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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.
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This review is from: The CE Mark: Understanding the Medical Device Directive (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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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 Key Phrases - Statistically Improbable Phrases (SIPs): (learn more)
conformity assessment route, active medical device, surgically invasive devices, full quality assurance system, notified body, central circulatory system, conformity assessment procedures, notified bodies, implantable medical devices, device classification, harmonized standards, measuring function, medical device manufacturers Key Phrases - Capitalized Phrases (CAPs): (learn more)
European Union, Class Ila, Class Ilb, Understanding the Medical Device Directive New!
Books on Related Topics | Concordance | Text Stats Browse Sample Pages:
Front Cover | Table of Contents | First Pages | Index | Back Cover | Surprise Me!
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 Key Phrases - Statistically Improbable Phrases (SIPs): (learn more)
conformity assessment route, active medical device, surgically invasive devices, full quality assurance system, notified body, central circulatory system, conformity assessment procedures, notified bodies, implantable medical devices, device classification, harmonized standards, measuring function, medical device manufacturers Key Phrases - Capitalized Phrases (CAPs): (learn more)
European Union, Class Ila, Class Ilb, Understanding the Medical Device Directive New!
Books on Related Topics | Concordance | Text Stats Browse Sample Pages:
Front Cover | Table of Contents | First Pages | Index | Back Cover | Surprise Me!
Citations (learn more)
This book cites 2
books:
- Public Finance by J. Richard Aronson in Front Matter
- Conformity Assessment by Iso on page 63
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