{"product_id":"excellence-beyond-compliance","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\n\u003cp\u003e\u003c\/p\u003e\n\u003cli\u003eAdvice that will lead to an effective and efficient QMS.\u003c\/li\u003e\n\u003cp\u003e\u003c\/p\u003e\n\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\n\u003cp\u003e\u003c\/p\u003e\n\u003cp\u003e\u003c\/p\u003e\n\u003cli\u003eDetailed ideas on how to execute those decisions.\u003c\/li\u003e\n\u003cp\u003e\u003c\/p\u003e\n\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\n\u003cp\u003e\u003c\/p\u003e\n\u003cp\u003e\u003c\/p\u003e\n\u003cli\u003eSpecific examples of procedures.\u003c\/li\u003e\n\u003cp\u003e\u003c\/p\u003e\n\u003cp\u003e\u003c\/p\u003e\n\u003cli\u003eInformation regarding requirements for combination products, such as a drug + device combination.\u003c\/li\u003e\n\u003cp\u003e\u003c\/p\u003e\n\u003cp\u003e\u003c\/p\u003e\n\u003cli\u003eAdvice on incorporating risk management in the QMS.\u003c\/li\u003e\n\u003cp\u003e\u003c\/p\u003e\n\u003c\/ul\u003e","brand":"None","offers":[{"title":"Hardcover","offer_id":46212406673618,"sku":"9781138491472","price":93.5,"currency_code":"CAD","in_stock":true},{"title":"Kobo eBook","offer_id":46212406706386,"sku":"b4089992-b3a8-31dd-9003-56aef99b3460","price":85.49,"currency_code":"CAD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0655\/8980\/5233\/files\/1_e5d06e9a-f4a8-4090-901f-02e1220a0f9c.jpg?v=1763108100","url":"https:\/\/www.indigo.ca\/products\/excellence-beyond-compliance","provider":"Indigo","version":"1.0","type":"link"}