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Medical devices are widely used - from prevention and diagnostics to treatment and rehabilitation. They are indispensable for the health sector, and do represent an important economic factor. Efficacy and safety of a product is of key importance for patients and users. CE-marking has to be affixed on all medical devices in Europe and is the visible feature of conformity of the medical device with essential legal requirements. CE-marking therefore is one of the most important objectives for manufacturers that want to distribute medical devices in Europe. The authors are working in the medical devices industry for many years. With their expertise they provide a competent but also practice-oriented overview of the European and national requirements for medical devices. This book is meant to be a workbook including exercises to deepen the knowledge on the CE-marking process for medical devices.
About the author
Ph.D., biologist and chemist by education, has more than 18 years of experience in the field of medical devices as well as in the field of national and international medical device legislation - at Allergan Medical Optics (AMO) and Abbott Medical Optics. As "Manager Regulatory Affairs EMEA" at AMO she was responsible for several years for the registration process of all medical devices for AMO¿s "Emerging Markets". Moreover, she has been an active member in several working groups of EUCOMED, MECOMED and EUROMCONTACT, which contributed to her overall understanding and expertise in this field. Sibylle offers more than 22 years of experience in the ophthalmic medical device industry which resulted in high expertise and thorough understanding of developments, processes and future trends.
