{"product_id":"drug-device-combination-products-shane-robinson-9798315875949","title":"Drug Device Combination Products","description":"\u003cb\u003eBook Overview: \u003ci\u003eDrug-Device Combination Products: Design, Regulation, and Performance\u003c\/i\u003e\u003c\/b\u003e\u003cbr\u003eIn an era of rapidly evolving healthcare technology, \u003ci\u003eDrug-Device Combination Products\u003c\/i\u003e by Shane Robinson serves as an essential guide to one of the most complex and dynamic segments of modern medicine. This comprehensive handbook offers an in-depth exploration of combination products-therapeutic innovations that integrate pharmaceutical drugs, medical devices, and biologics to create unified solutions for enhanced patient care.\u003cbr\u003eThrough meticulously detailed chapters, the book navigates the scientific, regulatory, and engineering challenges involved in developing these products. From pre-filled syringes and auto-injectors to advanced pen injector systems, readers gain insight into real-world examples of how these systems are transforming treatment delivery for chronic conditions such as diabetes, asthma, and cardiovascular disease.\u003cbr\u003eThe text delves into regulatory frameworks including FDA's 21 CFR Part 4 and the EU Medical Device Regulation (MDR 2017\/745), guiding readers through compliance with quality systems, design controls, and risk management. The integration of ISO standards such as ISO 13485 and ISO 14971 further reinforces the book's focus on global harmonization.\u003cbr\u003eRobinson expertly outlines critical topics such as usability engineering, biocompatibility testing, performance validation, and lifecycle management. With technical depth and regulatory clarity, the book bridges pharmaceutical sciences, biomedical engineering, and quality assurance-offering practical tools for industry professionals, regulatory specialists, and developers of combination products.\u003cbr\u003eWhether for those new to the field or seasoned professionals seeking up-to-date reference material, \u003ci\u003eDrug-Device Combination Products\u003c\/i\u003e delivers a foundational yet forward-looking perspective on creating safe, effective, and compliant therapeutic technologies. \u003cp\u003e\u003c\/p\u003eIntroduction to Combination Products\u003cbr\u003eFDA and EU Definitions of Combination Products\u003cbr\u003eRegulatory Frameworks: FDA 21 CFR Part 4 and EU MDR 2017\/745\u003cbr\u003eTypes of Combination Products (Single-entity, Co-packaged, Cross-labelled)\u003cbr\u003eDesign Controls for Combination Products\u003cbr\u003eRisk Management in Combination Product Development\u003cbr\u003eEssential Performance Requirements (EPRs) and EDDOs\u003cbr\u003eHuman Factors and Usability Engineering\u003cbr\u003eDesign Inputs and Design Outputs\u003cbr\u003eVerification and Validation Testing\u003cbr\u003eClinical Evaluation and Performance Requirements\u003cbr\u003eTechnical Considerations for Pen Injectors and Auto-Injectors\u003cbr\u003eMaterial Selection and Compatibility for Drug-Device Systems\u003cbr\u003eBiocompatibility Testing per ISO 10993-1\u003cbr\u003eSterility and Container Closure Integrity Testing\u003cbr\u003eShelf Life and Stability Studies\u003cbr\u003eUsability Design and Risk Mitigation by Design\u003cbr\u003ePerformance Testing: Injection Time, Force, Dose Accuracy\u003cbr\u003eSoftware Integration and Medical Device Software Safety\u003cbr\u003ePost-Market Surveillance and Vigilance Systems\u003cbr\u003eLabeling and Instructions for Use (IFU)\u003cbr\u003eDesign Change Management and Lifecycle Control\u003cbr\u003eClinical Trials and Post-Market Clinical Follow-Up (PMCF)\u003cbr\u003eApplication of ISO 13485 and ISO 14971\u003cbr\u003eProtective Measures and Information for Safety\u003cbr\u003ePackaging and Environmental Use Conditions\u003cbr\u003eDesign History File (DHF) and Risk Management File (RMF)\u003cbr\u003eSterilisation Techniques and Aseptic Processing\u003cbr\u003eAutomation and Electronics in Needle-Based Injection Systems\u003cbr\u003eEU GMP Annexes and Manufacturing for Sterile Products\u003cbr\u003e\u003cbr\u003e\u003cb\u003eAuthor:\u003c\/b\u003e Shane Robinson\u003cbr\u003e\u003cb\u003eISBN-13:\u003c\/b\u003e 9798315875949\u003cbr\u003e\u003cb\u003ePublisher:\u003c\/b\u003e Independently Published\u003cbr\u003e\u003cb\u003eLanguage:\u003c\/b\u003e English\u003cbr\u003e\u003cb\u003ePublished:\u003c\/b\u003e 04\/14\/2025\u003cbr\u003e\u003cb\u003ePages:\u003c\/b\u003e 294\u003cbr\u003e\u003cb\u003eFormat:\u003c\/b\u003e Paperback\u003cbr\u003e\u003cb\u003eWeight:\u003c\/b\u003e 0.87lbs\u003cbr\u003e\u003cb\u003eSize:\u003c\/b\u003e 9.00h x 6.00w x 0.62d","brand":"Shane Robinson","offers":[{"title":"Paperback","offer_id":46962289311999,"sku":"9798315875949","price":29.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0662\/2982\/9887\/files\/img_4d5a4e70-bdc1-4964-b05e-4983ac29221a.jpg?v=1750649902","url":"https:\/\/www.whiterainbookhouse.com\/products\/drug-device-combination-products-shane-robinson-9798315875949","provider":"WR Book House","version":"1.0","type":"link"}