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The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
For 20 years, our flagship publication, Fundamentals of US Regulatory Affairs, has been giving regulatory professionals the insights and answers they need, right at their fingertips.
There are hundreds of RAC testing centers available worldwide. Any of the four RAC exams (US, EU, CAN or Global) may be taken at any location. Find an upcoming exam at a location near you.
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DEKRA Certification is a world-class Notified Body, with offices in the US, The Netherlands, Germany, Switzerland, Israel and Japan. We offer full-service, “one-stop-shopping” for CE marking of medical devices, certification of Quality Management Systems (including CMDCAS), and Notified Body transfers. Special consideration given to startup/early stage medical device companies working with advanced technologies. We provide Regulatory Strategy Review and Clinical Protocol Review services in order to avoid unexpected ‘surprises’ (delays) during the certification process. Our in-house product experts are experienced in cardiovascular, neurovascular, minimal invasive surgery, active implantables, IVD’s, drug/device combinations and devices with animal tissue components.
1850 Gateway Boulevard, Suite 925 Concord , California 94520 United States Phone: 925-283-7535 Fax: 925-305-2751 Email: ray.milne@DEKRA.com
Dr. Ray Milne Business Development Manager
Dr. Jeff Schakenraad Business Team Manager (US)