Overview
This book is a practical guide to meeting IEC 62304 software development requirements within the context of an ISO 13485 quality management system (QMS). It proves it can be done with a minimum amount of friction, overlap, and back-and-forth between development stages.
While major retailers like Amazon may carry Medical-Grade Software Development (How to Build Medical-Device Products That Meet the Requirements of IEC 62304 and ISO 13485), we specialize in bulk book sales and offer personalized service from our friendly, book-smart team based in Portland, Oregon. We’re proud to offer a Price Match Guarantee and a streamlined ordering experience from people who truly care.
We’re trusted by over 75,000 customers, many of whom return time and again. Want proof? Just check out our 25,000+ customer reviews—real feedback from people who love how we do business.
Prefer to talk to a real person? Our Book Specialists are here Monday–Friday, 8 a.m. to 5 p.m. PST and ready to help with your bulk order of Medical-Grade Software Development (How to Build Medical-Device Products That Meet the Requirements of IEC 62304 and ISO 13485).