Cohen i glenn editor (15 resultados)

trade paperback. Condición: Near Fine. Like new, appears unread. 280 pages, 9" x 6'' - Medical Device Regulation provides the current FDA-CDRH thinking on the regulation of medical devices. This book offers information on how devices meet criteria for being a medical device, which agencies regulate medical devices, how policies regarding regulation affect the market, rules regarding marketing, and laws and standards that govern testing. This practical, well-structured reference tool helps medical device manufacturers both in and out of the United States with premarket application and meeting complex FDA regulatory requirements. The book delivers a comprehensive overview of the field from an author with expertise in regulatory affairs and commercialization of medical devices. Offers a unique focus on the regulatory affairs industry, specifically targeted at regulatory affairs professionals and those seeking certification Puts regulations in the context of contemporary design Includes case studies and applications of regulations.--- Regulators have been more permissive for medical devices compared to their drug and biologic counterparts. While innovative products can thereby reach consumers more quickly, this approach raises serious public health and safety concerns. Additionally, the nature of medical devices is rapidly changing, as software has become as important as hardware. Regulation must keep pace with the current developments and controversies of this technology. This volume provides a multidisciplinary evaluation of the ethical, legal, and regulatory concerns surrounding medical devices in the US and EU. For medical providers, policymakers, and other stakeholders, the book offers a framework for the opportunities and challenges on the horizon for medical device regulation. Readers will gain a nuanced overview of the latest developments in patient privacy and safety, innovation, and new regulatory laws.…

hardcover. Condición: Used: Very Good. Clean and unmarked. Some minor cosmetic shelf wear. From a private collection. Very good condition. Comes from non smoking home.

Paperback. Condición: Like New. First Edition. In nearly new condition: firm and square with strong joints, no creases. Just a few hardly noticeable rubs. Hence a non-text page shows a small 'damaged' stamp. Despite such this book looks and feels unread. Thus the contents are crisp, fresh and tight. And so a very nice book in great condition, now offered for sale at a reasonable price. …

Hardcover. Condición: Like New. First Edition. Hardback book in nearly new condition with just a small publisher's 'damaged' stamp; even so not showing any defects, no splits, no cracks, no pen-marks, just some very minor surface rubbing and moderate shelf wear. Contents are crisp, tight and fresh. Thus a never read book still in very presentable condition now offered for sale at a sensible price. …

Paperback. Condición: Brand New. 1st edition. 291 pages. 8.75x6.00x0.75 inches. In Stock.

Paperback. Condición: Brand New. 1st edition. 361 pages. 9.00x6.00x1.00 inches. In Stock.

Hardcover. Condición: Brand New. 1st edition. 361 pages. 9.50x6.25x1.25 inches. In Stock.

Hardcover. Condición: Brand New. 1st edition. 551 pages. 9.00x6.50x1.25 inches. In Stock.

hardcover. Condición: Very Good.

Hardcover. Condición: Brand New. 1st edition. 361 pages. 9.50x6.25x1.25 inches. In Stock.

Paperback. Condición: Brand New. 1st edition. 354 pages. 8.75x6.00x1.00 inches. In Stock.

Hardcover. Condición: Brand New. 427 pages. 9.50x6.50x1.00 inches. In Stock.

Hardcover. Condición: Brand New. 1st edition. 1196 pages. 10.00x7.25x2.75 inches. In Stock.

Hardcover. Condición: Brand New. 1st edition. 354 pages. 9.25x6.25x0.75 inches. In Stock.

Hardcover. Condición: Brand New. 1st edition. 551 pages. 9.00x6.50x1.25 inches. In Stock. This item is printed on demand.