Simplifying Global Compliance
The US has a new president, a new Congress, and almost assuredly a new agenda for the FDA — with different policies and priorities than the current administration. What does this mean for FDA regulated industries?
ISO 13485:2016 — A Devicemaker’s Transition Guide has done the work for you — saving you valuable time to make plans and put them in action. It has a clause-by-clause, line-by-line, 46-page comparison of the old and new versions of 13485 that shows you exactly what and where the new requirements are.
Clinical Research Manual brings together guidance on everything from pharmacokinetics and study design, to recruitment, monitoring, statistics… all the problem compliance areas you need to stay on top of to conduct clinical trials that will stand up to regulatory scrutiny.
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