TY - BOOK ID - 92539975 TI - The future of medical device regulation : innovation and protection AU - Cohen, I. Glenn AU - Minssen, Timo AU - Price, W. Nicholson AU - Robertson, Christopher Tarver AU - Shachar, Carmel PY - 2022 SN - 9781108972055 9781108838634 9781108975452 PB - Cambridge : Cambridge University Press, DB - UniCat KW - Medical instruments and apparatus KW - Matériel médical KW - Law and legislation KW - Droit KW - Medical laws and legislation KW - Drugs KW - Products liability KW - Médecine KW - Médicaments KW - Responsabilité du fait des produits KW - Medical instruments and apparatus. KW - Droit. KW - Médicaments. KW - Matériel médical KW - Médecine KW - Médicaments KW - Responsabilité du fait des produits KW - Médicaments. UR - https://www.unicat.be/uniCat?func=search&query=sysid:92539975 AB - Regulators have been more permissive for medical devices compared to their drug and biologic counterparts. While innovative products can thereby reach consumers more quickly, this approach raises serious public health and safety concerns. Additionally, the nature of medical devices is rapidly changing, as software has become as important as hardware. Regulation must keep pace with the current developments and controversies of this technology. This volume provides a multidisciplinary evaluation of the ethical, legal, and regulatory concerns surrounding medical devices in the US and EU. For medical providers, policymakers, and other stakeholders, the book offers a framework for the opportunities and challenges on the horizon for medical device regulation. Readers will gain a nuanced overview of the latest developments in patient privacy and safety, innovation, and new regulatory laws. ER -