With this book, you get a really complete seminar for the new Regulations on medical devices and IVDs in the EU, ready at hand, at any time.
These EU regulations create new rules for medical technology and laboratory diagnostics in Europe. Concise regulatory know-how is now required to keep or reposition medical devices and in vitro diagnostics on the European market, from syringes, contact lenses, medical device apps, pregnancy tests, nuclear magnetic resonance tomography to cancer tests, genetic diagnostics, HIV tests, hip implants, heart catheters, artificial spinal discs, stents and pacemakers. Concise regulatory training and further education of employees in companies and health care facilities is the order of the day. This also applies to biomedical and medical technology students at universities of applied sciences and biomedical universities, start-ups and spin-offs, who must make use of this know-how from the initial product idea through the further stages of product development to market access.
The book provides a thorough, compact course on the new regulations, starting with perfect overview and easy navigation and going into depth where you need it: this book will make you fit and confident for the new European challenges!
344 pages; 47 col. figures; 26 tables
关于作者
Hon(FH)Prof. Dr. Wolfgang Ecker, MD, has played an active role in shaping the new EU regulations in the EU Council. He conveys the necessary know-how first-hand as former head of department in the Austrian Ministry of Health member in the important committees and working groups of the EU for medical devices and IVDs. He holds lectures at universities of applied sciences for medical technology and biomedical engineering and lectures for health and medical technology clusters as well as for players in business and healthcare.
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