{"product_id":"excellence-beyond-compliance-establishing-a-medical-device-quality-system-hardcover","title":"Excellence Beyond Compliance: Establishing a Medical Device Quality System - Hardcover","description":"\u003cdiv\u003e\u003cp style=\"text-align: right;\"\u003e\u003ca href=\"https:\/\/reportcopyrightinfringement.com\/\" target=\"_blank\" rel=\"nofollow\"\u003e\u003cb\u003eReport copyright infringement\u003c\/b\u003e\u003c\/a\u003e\u003c\/p\u003e\u003c\/div\u003e\u003cp\u003eby \u003cb\u003eWilliam I. White\u003c\/b\u003e (Author)\u003c\/p\u003e\u003cp\u003e\u003c\/p\u003e\u003cp\u003eMany companies limp along from day-to-day treating the quality side of the business as a necessary evil, and doing only what is minimally necessary for compliance to regulations. This kind of approach to compliance almost always results in inefficiencies and sometimes can result in a curious kind of noncompliance. Documentation created with compliance as the sole consideration often ends up confusing the employees who must use the documentation.\u003c\/p\u003e \u003cp\u003e\u003c\/p\u003e \u003cp\u003eThis book looks beyond what is necessary for compliance alone to address what makes a quality management system (QMS) both effective and efficient. This book also never forgets that real people must make any QMS work; the book provides a blueprint for creating a QMS that real people will find useful.\u003c\/p\u003e \u003cp\u003e\u003c\/p\u003e \u003cp\u003eAfter a review of the challenges that any medical device company faces in the world of today-the multiple sources of QMS requirements-the book poses a question: are we satisfied with the QMS we have now, or could we do better? If we want to do better, this book can help.\u003c\/p\u003e \u003cp\u003e\u003c\/p\u003e \u003cp\u003eThis book offers: \u003c\/p\u003e \u003cul\u003e \u003cp\u003e \u003c\/p\u003e\n\u003cli\u003eAdvice that will lead to an effective and efficient QMS.\u003c\/li\u003e \u003cp\u003e\u003c\/p\u003e \u003cp\u003e \u003c\/p\u003e\n\u003cli\u003eDetailed guidance on the key decisions to be made regarding the quality system being established.\u003c\/li\u003e \u003cp\u003e\u003c\/p\u003e \u003cp\u003e \u003c\/p\u003e\n\u003cli\u003eDetailed ideas on how to execute those decisions.\u003c\/li\u003e \u003cp\u003e\u003c\/p\u003e \u003cp\u003e \u003c\/p\u003e\n\u003cli\u003eUp-to-date information on compliance to current regulations and standards and guidance on staying up to date.\u003c\/li\u003e \u003cp\u003e\u003c\/p\u003e \u003cp\u003e \u003c\/p\u003e\n\u003cli\u003eSpecific examples of procedures.\u003c\/li\u003e \u003cp\u003e\u003c\/p\u003e \u003cp\u003e \u003c\/p\u003e\n\u003cli\u003eInformation regarding requirements for combination products, such as a drug + device combination.\u003c\/li\u003e \u003cp\u003e\u003c\/p\u003e \u003cp\u003e \u003c\/p\u003e\n\u003cli\u003eAdvice on incorporating risk management in the QMS.\u003c\/li\u003e \u003cp\u003e\u003c\/p\u003e\n\u003ch3\u003eAuthor Biography\u003c\/h3\u003e\n\u003cp\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eBill White\u003c\/strong\u003e started Quality System Strategies LLC in 2006 after 30 years at Bayer HealthCare LLC. At Bayer, after 20 years in R\u0026amp;D he worked with colleagues in the mid 1990s to establish the design control system for the diagnostics division. He then became Manager, Quality Systems Strategy, and in that role served as principal architect for the worldwide quality system of the division. \u003c\/p\u003e \u003cp\u003eSince retiring from Bayer, he has advised medical device companies ranging in size from a few persons to several thousand persons on how best to fulfill requirements of 21 CFR 820 and ISO 13485 while creating quality systems that serve the needs of the companies and their employees. \u003c\/p\u003e \u003cp\u003eDr. White holds an A.B. in Chemistry from Harvard College and a PhD in Chemistry from Cornell University. \u003c\/p\u003e\n            \u003cdiv\u003e\n\u003cstrong\u003eNumber of Pages:\u003c\/strong\u003e 216\u003c\/div\u003e\n            \u003cdiv\u003e\n\u003cstrong\u003eDimensions:\u003c\/strong\u003e 0.56 x 9.21 x 6.14 IN\u003c\/div\u003e\n            \u003cdiv\u003e\n\u003cstrong\u003eIllustrated:\u003c\/strong\u003e Yes\u003c\/div\u003e\n            \u003cdiv\u003e\n\u003cstrong\u003ePublication Date:\u003c\/strong\u003e May 24, 2018\u003c\/div\u003e\n            \u003c\/ul\u003e","brand":"BooksCloud","offers":[{"title":"Default Title","offer_id":52478841094451,"sku":"9781138491472","price":109.04,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0300\/5595\/6612\/files\/T2VaWEsxK1U3WStYbmV1WUlkNGg1Zz09.webp?v=1759661984","url":"https:\/\/www.vysn.com\/products\/excellence-beyond-compliance-establishing-a-medical-device-quality-system-hardcover","provider":"VYSN","version":"1.0","type":"link"}