Risk Management for Medical Device Manufacturers

by Joe Simon

As a quality professional in the medical device industry, you know all too well the importance of a risk management process―and how iterative it can be. Industry regulations and standards―like ISO 14971―help medical device manufacturers define risk management processes, but they don’t make them “bulletproof”―that is, ensure the efficacy of their products while minimizing future liability. This book can help you build a “bulletproof” risk process. You will learn • Designing product and manufacturing processes controls risks • Using consistent language in a holistic, closed-loop risk management system leads to greater efficiency • Creating useable and audit-ready risk documents can support verification/validation (V/V) sampling plans • Developing labels and instructions can help end-users and patients clearly understand the pertinent risks • Creating post-market surveillance (PMS) processes is essential to determine if additional clinical/performance studies are necessary

258 pages, Paperback

Published January 31, 2022

About the author

Joseph Henry "Joe" Simon (born Hymie Simon) was an American comic book writer, artist, editor, and publisher. Simon created or co-created many important characters in the 1930s-1940s Golden Age of Comic Books and served as the first editor of Timely Comics, the company that would evolve into Marvel Comics.

With his partner, artist Jack Kirby, he co-created Captain America, one of comics' most enduring superheroes, and the team worked extensively on such features at DC Comics as the 1940s Sandman and Sandy the Golden Boy, and co-created the Newsboy Legion, the Boy Commandos, and Manhunter. Simon & Kirby creations for other comics publishers include Boys' Ranch, Fighting American and the Fly. In the late 1940s, the duo created the field of romance comics, and were among the earliest pioneers of horror comics. Simon, who went on to work in advertising and commercial art, also founded the satirical magazine Sick in 1960, remaining with it for a decade. He briefly returned to DC Comics in the 1970s.

Simon was inducted into the Will Eisner Comic Book Hall of Fame in 1999.