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This compilation includes the individual medical device subsets from all four Fundamentals of Regulatory Affairs books: US, EU, Canada and International. The subsets cover the entire medical device lifecycle, from product development through postmarketing for all these regions.
The second edition of Global Medical Device Regulatory Strategy includes timely updates on all chapters, current information on cybersecurity and software, new international regulations and a new chapter on driving successful commercial product launches.
Regulatory Writing is an invaluable resource for any professional engaged in designing, composing, compiling, or commenting on regulatory documentation.
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Developed exclusively for RAPS members, Regipedia is a growing collection of more than 2,300 regulatory terms, definitions and acronyms. Individual terms are cross-referenced by region and sector and many include additional access to current sources and references. Regipedia is your direct entry into today’s most relevant and timely global regulatory knowledge base. Log into your account today and see how Regipedia can help expand and enhance your knowledge of the regulatory landscape.
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