Rockville, MD USA—The Regulatory Affairs Professionals Society (RAPS) is offering two valuable resources—a workshop and a new book—for professionals and students interested in the regulation of medical devices. The workshop, entitled Medical Device Submission & Compliance Strategies for the US Market, will take place 5–7 March in Rockville, MD, and is designed to help regulatory professionals navigate the clearance process for medical devices in the US. The new reference book, Global Medical Device Regulation, covers device regulations across multiple global markets and is available for purchase online.
“Learning and keeping up with the latest regulations governing medical devices, in the US and around the world, is crucial for regulatory professionals at all levels,” said Sherry Keramidas, PhD, FASAE, CAE. “RAPS’ research shows that more than half of regulatory professionals are involved in some way with medical devices.”
RAPS’ workshop will feature expert advice from US Food and Drug Administration (FDA) regulators and an experienced panel of industry professionals on topics, including how to produce effective compliance strategies and successfully communicate with FDA. Maximum capacity for in-person attendance for the Medical Device Submission & Compliance for the US Market workshop has been reached, however, it is still possible to register and participate virtually.
RAPS’ new publication, Global Medical Device Regulation, is a compilation of chapters adapted from the five books in RAPS’ Fundamentals of Regulatory Affairs series. This comprehensive book addresses everything from essential, broadly applicable regulatory information and concepts to the specific regulations governing medical devices and in vitro medical devices. It is based largely on Global Harmonization Task Force and ISO requirements, and regulations in the US, EU, Canada and Japan. The concept for the book arose from a request from Grace College in Winona Lake, IN, for material for a course on device regulations, and it will now be used as the text for that class.
The Regulatory Affairs Professionals Society (RAPS) is an international membership organization of regulatory professionals in the rapidly growing medical device, pharmaceutical and biotechnology sectors. Regulatory professionals play vital roles in making better healthcare products possible. They work throughout the healthcare product lifecycle, ensuring these products are safe and effective, while driving organizational strategy and sound decision-making. RAPS supports these individuals and the regulatory profession by providing education and training, Regulatory Affairs Certification (RAC), professional standards, research, knowledge-sharing, publications, networking, career development opportunities and other valuable resources; and is committed to helping its members continually develop the knowledge and skills they need to excel. RAPS is headquartered near Washington, DC, with offices in Brussels and Tokyo. RAPS.org