Medical Device Quality Assurance and Regulatory Compliance

Hjortso, Martin

Sarkodie-Gyan, Thompson

<i> <p>Extracellular Matrix-Derived Implants in Clinical Medicine </i>comprehensively covers the emergence of tissue engineering and regenerative medicine over the past few decades, along with discussions of continuous funding and research.</p> <p>The book provides a state-of-the-art review of this increasingly important technology and how it is translating from bench to bedside. Part One of the book looks at the historical use of human and animal tissues, focusing on the main application areas, including cardiovascular, hard and soft tissue engineering, and neurological, while Part Two examines the challenges in harvesting, processing, and manufacturing of extracellular matrices, with a final section reviewing the international regulatory environment and economics of tissue-based products.</p>

Ramalingam, Murugan

<p><i>Material-Tissue Interfacial Phenomena: Contributions from Dental and Craniofacial Reconstructions </i>explores the material/tissue interfacial phenomena using dental and craniofacial reconstructions as a model system. As the mouth is a particularly caustic environment, the synthetic and/or bio-enabled materials used to repair damaged tissues and restore form, function, and esthetics to oral structures must resist a variety of physical, chemical, and mechanical challenges. </p> <p>These challenges are magnified at the interface between dissimilar structures such as the tooth/material interface. Interfacial reactions at the atomic, molecular, and nano-scales initiate the failure of materials used to repair, restore, and reconstruct dental and craniofacial tissues. </p> <p>Understanding the phenomena that lead to failure at the interface between dissimilar structures, such as synthetic materials and biologic tissues, is confounded by a variety of factors that are thoroughly discussed in this comprehensive book.</p>

<p><i>Biofilms and Implantable Medical Devices: Infection and Control</i> explores the increasing use of permanent and semi-permanent implants and indwelling medical devices. As an understanding of the growth and impact of biofilm formation on these medical devices and biomaterials is vital for protecting the health of the human host, this book provides readers with a comprehensive treatise on biofilms and their relationship with medical devices, also reporting on infections and associated strategies for prevention.</p>