{"product_id":"9781138491472","title":"Excellence Beyond Compliance: Establishing a Medical Device Quality System","description":"\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  \u003cli\u003eAdvice that will lead to an effective and efficient QMS.\u003c\/li\u003e \u003cp\u003e\u003c\/p\u003e  \u003cli\u003eDetailed guidance on the key decisions to be made regarding the quality system being established.\u003c\/li\u003e \u003cp\u003e\u003c\/p\u003e  \u003cli\u003eDetailed ideas on how to execute those decisions.\u003c\/li\u003e \u003cp\u003e\u003c\/p\u003e  \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  \u003cli\u003eSpecific examples of procedures.\u003c\/li\u003e \u003cp\u003e\u003c\/p\u003e  \u003cli\u003eInformation regarding requirements for combination products, such as a drug + device combination.\u003c\/li\u003e \u003cp\u003e\u003c\/p\u003e  \u003cli\u003eAdvice on incorporating risk management in the QMS.\u003c\/li\u003e \u003cp\u003e\u003c\/p\u003e\n\u003c\/ul\u003e","brand":"CRC Press","offers":[{"title":"Default Title","offer_id":47778361835760,"sku":"9781138491472","price":49.95,"currency_code":"USD","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0737\/7593\/9824\/files\/9781138491472_p0.jpg?v=1763700356","url":"https:\/\/shop-qa.barnesandnoble.com\/products\/9781138491472","provider":"Barnes \u0026 Noble (DEV)","version":"1.0","type":"link"}