Durch die Behandlung einer Vielzahl unterschiedlicher Produkttypen und der wichtigsten globalen
Märkte ist dieses Lehrwerk genau richtig für Kurse rund um Zulassungsfragen medizinischer
Geräte. Eignet sich auch hervorragend als Einführung in das Thema.
---------------------------------------- Building on the success of its predecessor this
second edition of the hands-on guide to how pharmaceutical and medical devices are regulated
within the major global markets has an even wider scope and now features case studies. The new
EU-framework and US regulations are also fully integrated. The textbook is based on a module
prepared by the authors for an MSc course. This and its broad coverage make it an ideal
resource for training purposes in both industry and academia. It is equally a valuable
reference for all scientists needing to familiarize themselves with the topic.
