We are proud to announce that Gretchen Parker PhD, RAC, CIP contributed a chapter to a recent publication entitled “Global Medical Device Regulatory Strategy” published by the Regulatory Affairs Professionals Society (RAPS, purchase required). This book provides a “how to” guide to developing a comprehensive global regulatory strategy for all types of medical devices.
Discussions cover medical device types, basic strategy components, and assembling a core development team from multiple departments to create a strong, viable strategy to market a product in more than one jurisdiction. There is information on device design and development elements, setting up a quality management system, labeling strategies, and manufacturing information. Other chapters look at the Notified Body’s viewpoint on regulatory strategy and that of regulators. Additional information is included in the book, including the use of standards that cover global regulatory processes and how patents apply to medical devices.
Further information about this publication may be found on the RAPS website. https://www.raps.org/ProductDetail.aspx?ProductId=96813130