{"product_id":"additive-manufacturing-for-orthopedic-implants-material-and-process-selection-validation-activities-and-regulatory-submissions-9781394215218","title":"Additive Manufacturing for Orthopedic Implants: Material and Process Selection, Validation Activities, and Regulatory Submissions","description":"\u003cp\u003e • Author(s): Meredith Price Vanderbilt | Dawn Abens Lissy | Brian McLaughlin\u003cbr\u003e • Publisher: Wiley\u003cbr\u003e • Publisher Imprint: Wiley\u003cbr\u003e • BISAC: 3D Printing\u003c\/p\u003e\u003cp\u003e\u003c\/p\u003e\u003cp\u003e\u003cb\u003eOffers a practical roadmap for successfully applying additive manufacturing to orthopedic implants\u003c\/b\u003e \u003c\/p\u003e\u003cp\u003eAs additive manufacturing (AM) transforms the orthopedic implant landscape, professionals are facing a growing need for guidance that connects advanced manufacturing techniques with practical regulatory and validation requirements. \u003ci\u003eAdditive Manufacturing for Orthopedic Implants: Material and Process Selection, Validation Activities, and Regulatory Submissions\u003c\/i\u003e delivers exactly that--a clear, concise resource designed specifically for engineers, designers, and regulatory specialists working at the intersection of innovation and compliance. \u003c\/p\u003e\u003cp\u003eWritten by seasoned professionals with deep experience in additive technologies, mechanical testing, and regulatory environments, this book walks readers through the critical steps involved in developing spine, hip, knee, shoulder, and other implant products using additive manufacturing. The content spans the full product lifecycle, from design and prototyping to process validation and FDA submission preparation. Key insights into various AM technologies and post-processing methods are grounded in real-world examples and case studies that illuminate common challenges and successful solutions. \u003c\/p\u003e\u003cp\u003eProviding the essential tools for navigating a complex and rapidly evolving field, \u003ci\u003eAdditive Manufacturing for Orthopedic Implants: \u003c\/i\u003e \u003c\/p\u003e\u003cul\u003e\n\u003cli\u003eClarifies material selection criteria specific to different implant types and AM technologies\u003c\/li\u003e \u003cli\u003eExplores the interplay between design freedom and regulatory expectations in patient-specific implants\u003c\/li\u003e \u003cli\u003eHighlights common failure modes and risk mitigation strategies in AM orthopedic manufacturing\u003c\/li\u003e \u003cli\u003eAddresses facility, inspection, and documentation needs to meet compliance and audit standards\u003c\/li\u003e \u003cli\u003eFeatures decision-making aids, checklists, and process validation frameworks to support practical implementation\u003c\/li\u003e \u003cli\u003eDemystifies the regulatory requirements specific to additively manufactured products\u003c\/li\u003e\n\u003c\/ul\u003e \u003cp\u003eIntegrating insights from multiple disciplines, including biomedical engineering, regulatory affairs, and quality assurance, \u003ci\u003eAdditive Manufacturing for Orthopedic Implants: Material and Process Selection, Validation Activities, and Regulatory Submissions\u003c\/i\u003e is essential for professionals working in medical device manufacturing, particularly those developing orthopedic implants using additive technologies. It is also suitable for graduate-level courses in biomedical engineering, additive manufacturing, and medical device design.\u003c\/p\u003e","brand":"Wiley","offers":[{"title":"Hardcover","offer_id":47966725243031,"sku":"9781394215218","price":7249.0,"currency_code":"INR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0666\/3471\/1191\/files\/9781394215218.webp?v=1782912021","url":"https:\/\/atlanticbooks.com\/products\/additive-manufacturing-for-orthopedic-implants-material-and-process-selection-validation-activities-and-regulatory-submissions-9781394215218","provider":"Atlantic Books","version":"1.0","type":"link"}