When it comes to producing, marketing, and shipping medical devices within or into the European Union, ignorance isn't bliss. Keeping current and well versed on CE Mark requirements, though, can be a challenge. The regulations can be technical and difficult to understand. Certain sections apply to certain manufacturer types, but not to others. And deciphering specific requirements can take weeks--even months.

 

In this book, Les Schnoll describes the evolution of the CE Mark and explains its requirements in simple, easy-to-understand terms. He outlines the medical device directives article by article, illustrating which apply to which device and manufacturer type. Inside you'll find chapters about the important role of Notified Bodies in the CE marking process, explanations of the In-Vitro Diagnostic Directive and the Active Implantable Medical Device Directive, a comprehensive glossary, and several charts that plainly demonstrate how to classify device types. Other topics include:

Expert Advice
Les Schnoll is the senior director for quality systems at the biopharmaceutical company Theravance Inc. He's a member of the U.S. TAG to ISO/TC 176 and ISO/TC 210, and has more than thirty years of experience in quality assurance and control, auditing, and regulatory compliance in the medical device, pharmaceutical, and clinical/preclinical laboratory, industrial, and food industries. He's the author of The Regulatory Compliance Almanac, also published by Paton Professional.

 

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