Download or read book Medical Devices written by Christa Altenstetter and published by Routledge. This book was released on 2017-09-08 with total page 277 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical devices are the bread and butter from which health care and clinical research are derived. Such devices are used for patient care, genetic testing, clinical trials, and experimental clinical investigations. Without medical devices, there is no clinical research or patient care. Without life-adjusting devices, there are no medical procedures or surgery. Without life-saving and life-maintaining devices, there is no improvement in well-being and quality of life. Without innovative medical devices and experimentation, there can be no medical progress or patient safety. Medical devices and medical technology are used to create or support many different products and medical-surgical procedures. This volume on the regulation of medical devices in the European Union, with a focus on France, tackles a topic of interdisciplinary interest and significance for policymakers in countries around the globe. The EU regulatory regime is one of three global regional regimes, and medical products manufactured in EU countries are sold worldwide. As countries confront an aging population on a global scale, with associated increases in chronic diseases, physical handicaps, and multi-morbidity, there will inevitably be an increase in the demand for health services and, concomitantly, the use of medical devices in medical and surgical procedures. This will be the case regardless of whether services are delivered in hospitals, doctors' offices, or at home. The associated risks of a particular device will be the same whatever the country of origin for the device, or where the need occurs. Revolutionary medical advances increase diagnostic capabilities, but they increase the potential of harm and risks to patients. Medical technologies and devices are used ethically most of the time; yet they have the potential for unethical use when scientific medicine is elevated over human life and death. Assumptions that are taken for granted can be dangerous to a patient's health. That is why our understanding of appropriate and effective regulation of medical devices is significant to all people on all continents.

Download or read book COVID 19 written by Institut national de santé publique du Québec. Centre d'expertise en retraitement des dispositifs médicaux and published by . This book was released on 2021 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Global atlas of medical devices 2022 written by World Health Organization and published by World Health Organization. This book was released on 2022-11-24 with total page 608 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Convention Du Conseil de L Europe Sur la Contrefa on Des Produits M dicaux Et Les Infractions Similaires Mena ant la Sant Publique written by Council of Europe and published by Council of Europe. This book was released on 2011-01-01 with total page 36 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Council of Europe Convention on the counterfeiting of medical products and similar crimes involving threats to public health aims at the criminalization of certain activities because of the danger they pose to public health: the manufacturing of counterfeit medical products; supplying, offering to supply and trafficking in counterfeit medical products; the falsification of documents linked to medical products; the unauthorized manufacturing or supplying of medicinal products and the marketing of medical devices that do not comply with conformity requirements. The Convention also covers preventive measures and addresses the legal situation of victims of the above-mentioned crimes. The Convention is the first international criminal law instrument in its field, providing States Parties with a clear legal framework to combat the serious and increasing threat to public health posed by the counterfeiting of medical products and other dangerous practices.

Download or read book Gestion des risques des dispositifs m dicaux written by Syndicat national de l'industrie des technologies médicales (France) and published by . This book was released on 2018 with total page 164 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Guide Pratique Des Dispositifs M dico Chirurgicaux written by Mariame Alhachimi and published by Omniscriptum. This book was released on 2011-05 with total page 280 pages. Available in PDF, EPUB and Kindle. Book excerpt: Dispositif médical, un terme qui généralement, ne dit pas grande chose au grand public. Cependant, c'est un élément fondamental et omniprésent du secteur sanitaire. Il sert à diagnostiquer des maladies, les prévenir, à suivre l'évolution et les traiter. Aujourd'hui, il existe une multitude de dispositifs médicaux (plus de 50000 produits). Ils font partie de notre quotidien, aussi bien dans l'hôpital que dans la vie de tous les jours. Ainsi, j'ai essayé de rédiger ce guide qui constitue un outil pratique, simple à utiliser et clair sur les dispositifs médicaux. Adressé aux professionnels de la santé, ce guide représente un catalogue rassemblant différentes informations sur les dispositifs médicaux utilisés en chirurgie. De ce fait, il comporte deux grands chapitres dont le premier concerne des généralités (définitions, classifications, réglementation, fabrication...) et le deuxième va plutôt ètre consacré aux différents dispositifs médico- chirugicaux. A la fin de ce guide, se trouve un index aplphabétique qui permet à l'utilisateur de retrouver facilement le dispositif médical qu'il recherche.

Download or read book Innovation and Protection written by I. Glenn Cohen and published by Cambridge University Press. This book was released on 2022-04-07 with total page 295 pages. Available in PDF, EPUB and Kindle. Book excerpt: A detailed analysis of the ethical, legal, and regulatory landscape of medical devices in the US and EU.

Download or read book L e sant et la t l m decine written by SALGUES Bruno and published by Lavoisier. This book was released on 2013-05-01 with total page 319 pages. Available in PDF, EPUB and Kindle. Book excerpt: La télémédecine ou la e-santé regroupent un ensemble d’applications des technologies de l’information et de la communication, lesquelles sont traitées dans cet ouvrage en partant d’idées simples. Cet ouvrage place le patient au cœur du système. La santé est vue sous cet angle à travers la multitude des technologies disponibles actuellement. L’acceptabilité de ces technologies par le patient, l’aidant et le professionnel de soin devient alors un élément clé. L’auteur liste les différentes applications ainsi que les briques matérielles et logicielles indispensables à leur réalisation. Quelques éléments de prospective complètent les évolutions récentes, comme le partage entre l’hôpital et les nouveaux lieux de soins tel le domicile du patient. L’ouvrage analyse les contraintes liées à la mise en place de ces dispositifs, en particulier les normes et certifications nécessaires, puis il aborde les différentes formations mises en œuvre au service du déploiement de ces solutions.

Download or read book Dispositifs m dicaux written by Isabelle Lucas-Baloup and published by . This book was released on 1996 with total page 384 pages. Available in PDF, EPUB and Kindle. Book excerpt: La matériovigilance, ce n'est pas seulement remplir et envoyer un formulaire, après le dysfonctionnement d'un dispositif médical. L'objet des 50 questions est d'expliquer aux praticiens, qu'ils soient chirurgiens, médecins, pharmaciens, paramédicaux, aux directeurs des établissements de santé publics et privés, aux présidents de CME, aux chefs de blocs opératoires et aux infirmiers qui y travaillent, aux fabricants et distributeurs, aux laboratoires d'essais, aux sous-traitants et aux techniciens chargés de la maintenance, aux " correspondants de matériovigilance " et à leurs suppléants, leurs devoirs et obligations nouvelles en raison du droit communautaire et des textes récents qui ont introduit en France le " droit de la matériovigilance ".

Download or read book Technological Innovation written by Annetine C. Gelijns and published by National Academies. This book was released on 1989 with total page 78 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Le pr parateur en pharmacie Guide th orique et pratique 2e ed written by GAZENGEL Jean-Marie and published by Lavoisier. This book was released on 2013-04-15 with total page 1858 pages. Available in PDF, EPUB and Kindle. Book excerpt: Le préparateur en pharmacie – Guide théorique et pratique, 2e édition, aborde avec clarté et simplicité les différents aspects du savoir polyvalent que l’on attend du préparateur, appelé à seconder les pharmaciens titulaires et adjoints dans maintes tâches de l’officine : dispensation, conseil et information du public, préparation et réalisation des PDA (préparations des doses à administrer), vigilance, accueil et vente, documentation, gestion des stocks, administration, hygiène, diététique et maintien à domicile… Le personnel de l’officine doit aujourd’hui exercer sa mission de conseil avec d’autant plus de clairvoyance que le public, exposé à un discours médiatique et publicitaire à forte consonance scientifique, dispose de produits cosmétiques et de thérapeutiques « alternatives » où le naturel et le végétal jouent un très grand rôle, mais où les risques de l’automédication imposent un effort de pharmacovigilance et de toxicovigilance accru. Cette nouvelle édition, entièrement réactualisée, constitue un guide de référence pour les futurs préparateurs en pharmacie en respectant le référentiel du brevet professionnel, ainsi qu’un outil indispensable à la formation continue des préparateurs en mettant à leur disposition une somme d’informations facilement accessibles. Elle est également fort utile aux étudiants en pharmacie, dont le cursus comprend de nombreux stages : d’initiation officinale, d’application des enseignements coordonnés et de pratique professionnelle.

Download or read book European Regulation of Medical Devices and Pharmaceuticals written by Nupur Chowdhury and published by Springer Science & Business. This book was released on 2014-04-29 with total page 190 pages. Available in PDF, EPUB and Kindle. Book excerpt: One of the primary functions of law is to ensure that the legal structure governing all social relations is predictable, coherent, consistent and applicable. Taken together, these characteristics of law are referred to as legal certainty. In traditional approaches to legal certainty, law is regarded as a hierarchical system of rules characterized by stability, clarity, uniformity, calculable enforcement, publicity and predictability. However, the current reality is that national legal systems no longer operate in isolation, but within a multilevel legal order, wherein norms created at both the international and regional level are directly applicable to national legal systems. Also, norm creation is no longer the exclusive prerogative of public officials of the state: private actors have an increasing influence on norm creation as well. Social scientists have referred to this phenomenon of interacting and overlapping competences as multilevel governance. Only recently have legal scholars focused attention on the increasing interconnectedness (and therefore the concomitant loss of primacy of national legal orders) between the global, European and national regulatory spheres through the concept of multilevel regulation. In this project the author uses multilevel regulation as a term to characterize a regulatory space in which the process of rule making, rule enforcement and rule adjudication (the regulatory lifecycle) is dispersed across more than one administrative or territorial level and amongst several different actors, both public and private. The author draws on the concept of a regulatory space, using it as a framing device to differentiate between specific aspects of policy fields. The relationship between actors in such a space is non-hierarchical and they may be independent of each other. The lack of central ordering of the regulatory lifecycle within this regulatory space is the most important feature of such a space. The implications of multilevel regulation for the notion of legal certainty have attracted limited attention from scholars and the demand for legal certainty in regulatory practice is still a puzzle. The book explores the idea of legal certainty in terms of the perceptions and expectations of regulatees in the context of medical products – specifically, pharmaceuticals and medical devices, which can be differentiated as two regulatory spaces and therefore form two case studies. As an exploratory project, the book necessarily explores new territory in terms of investigating legal certainty first in terms of regulatee perceptions and expectations and second, because it studies it in the context of multilevel regulation.

Download or read book Biological Evaluation of Medical Devices written by International Organization for Standardization and published by . This book was released on 2003 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Micro et nanosyst mes autonomes en nergie des applications aux fonctions et technologies Trait EGEM s rie lectronique et micro lectronique written by BELLEVILLE Marc and published by Lavoisier. This book was released on 2012-07-01 with total page 402 pages. Available in PDF, EPUB and Kindle. Book excerpt: Cet ouvrage propose un panorama détaillé des micro et nanosystèmes autonomes en énergie, couvrant à la fois les principes mis en oeuvre et les derniers développements. Une étude approfondie d'applications dans les domaines aéronautiques, médicaux et du contrôle des bâtiments permet de dresser les grandes spécifications de tels systèmes et de leurs sous-composants. Les techniques les plus récentes de récupération et conversion d'énergie d'origine photovoltaïque, thermique et mécanique sont présentées. Un état de l'art sur les interfaces capteurs, le traitement du signal numérique et les liaisons radiofréquence, ultra-basse consommation, complète ce panorama. Enfin, des techniques d'optimisation de l'énergie au niveau du microsystème/noeud de capteur et d'un réseau de capteurs sont introduites et discutées.

Download or read book Situations apprenantes written by Claudine Duteil and published by Lulu.com. This book was released on 2010 with total page 109 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Writing In House Medical Device Software in Compliance with EU UK and US Regulations written by Philip S. Cosgriff and published by CRC Press. This book was released on 2024-03-26 with total page 223 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is a comprehensive guide to producing medical software for routine clinical use. It is a practical guidebook for medical professionals developing software to ensure compliance with medical device regulations for software products intended to be sold commercially, shared with healthcare colleagues in other hospitals, or simply used in-house. It compares requirements and latest regulations in different global territories, including the most recent EU regulations as well as UK and US regulations. This book is a valuable resource for practising clinical scientists producing medical software in-house, in addition to other medical staff writing small apps for clinical use, clinical scientist trainees, and software engineers considering a move into healthcare. The academic level is post-graduate, as readers will require a basic knowledge of software engineering principles and practice. Key Features: Up to date with the latest regulations in the UK, the EU, and the US Useful for those producing medical software for routine clinical use Contains best practice

Download or read book Manuel des dispositifs m dicaux de soins standards written by and published by . This book was released on 2021 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: