標(biāo)題: Titlebook: Medical Devices and In Vitro Diagnostics; Requirements in Euro Christian Baumgartner,Johann Harer ,J?rg Schr?ttne Living reference work 202 [打印本頁] 作者: obesity 時間: 2025-3-21 16:39
書目名稱Medical Devices and In Vitro Diagnostics影響因子(影響力)
書目名稱Medical Devices and In Vitro Diagnostics影響因子(影響力)學(xué)科排名
書目名稱Medical Devices and In Vitro Diagnostics網(wǎng)絡(luò)公開度
書目名稱Medical Devices and In Vitro Diagnostics網(wǎng)絡(luò)公開度學(xué)科排名
書目名稱Medical Devices and In Vitro Diagnostics被引頻次
書目名稱Medical Devices and In Vitro Diagnostics被引頻次學(xué)科排名
書目名稱Medical Devices and In Vitro Diagnostics年度引用
書目名稱Medical Devices and In Vitro Diagnostics年度引用學(xué)科排名
書目名稱Medical Devices and In Vitro Diagnostics讀者反饋
書目名稱Medical Devices and In Vitro Diagnostics讀者反饋學(xué)科排名
作者: neutrophils 時間: 2025-3-22 00:10
The Notified Body: The Conformity Assessment Body for Medical Devices in Europe,ter, we present in detail what a Notified Body is in the sense of the aforementioned regulations and what special requirements are placed on designated notified bodies. We describe when a Notified Body is required for CE marking and what the main tasks of a Notified Body are in the conformity assess作者: 前奏曲 時間: 2025-3-22 01:24 作者: Evolve 時間: 2025-3-22 07:41 作者: 漸強(qiáng) 時間: 2025-3-22 10:17
Safety Requirements for Medical Devices in Compliance with European Standards,es to comply with the state of the art and how it can be achieved. It also provides a brief overview of the safety requirements of the medical device regulations, with a focus on single fault conditions and the philosophy of integrated safety, together with an attempt to identify possible ways of pr作者: 吹牛需要藝術(shù) 時間: 2025-3-22 13:25 作者: 都相信我的話 時間: 2025-3-22 18:49
Risk Management for Medical Devices in Compliance with EN ISO 14971,its implementation is outlined. In addition, the individual elements of the risk management process are described and discussed in detail. All documents that are considered as evidence of the establishment of a complete risk management process are presented, and their necessary content is shown. The作者: 粗魯性質(zhì) 時間: 2025-3-22 21:24
Medical Products: Packing and Labeling Requirements, practice. Other legislation, such as CLP and transport of hazardous materials, may apply and have to be considered as well. It has further become common practice that the manufacturer will consider providing information on safe or environmentally responsible disposal of packaging.作者: Scintillations 時間: 2025-3-23 02:22 作者: 微枝末節(jié) 時間: 2025-3-23 08:31 作者: 鎮(zhèn)壓 時間: 2025-3-23 13:29
Mastering Quality System Audits and Inspections for Medical Devices,fy that manufacturers, critical suppliers, and professional users have implemented a quality management system that meets legal requirements. This chapter describes and explains which legal and normative regulations determine the scope and content of audits and inspections, which types of audits and作者: Abrade 時間: 2025-3-23 16:50 作者: spondylosis 時間: 2025-3-23 20:51
Quality Management Requirements in Compliance with European Regulations,ment system of medical device and in vitro diagnostic manufacturers. The extent to which the EN ISO 13485 meets the requirements of the new EU regulations for medical devices and in vitro diagnostics is discussed. The basics of a quality management system, the responsibility of the management, resou作者: flaunt 時間: 2025-3-23 23:53
Validation of Methods and Analytical Processes for In Vitro Diagnostics, are tightly interlinked. In method development, analysis techniques and steps are defined that are later applied in method validation..A key question is: When is it necessary to validate or revalidate analytical methods? The answer is:.Numerous committees and publications have discussed and explain作者: absorbed 時間: 2025-3-24 04:15 作者: Lasting 時間: 2025-3-24 06:56 作者: Delectable 時間: 2025-3-24 11:15 作者: 無關(guān)緊要 時間: 2025-3-24 16:29 作者: Spinous-Process 時間: 2025-3-24 21:24
Manufacturing and Quality Assurance in Compliance with the MDR and IVDR,teria are achieved with a high probability during series production. In particular, this chapter describes how tests are to be carried out in the incoming goods, the process, and the final inspection department, which records are required in production, and how the current product status can be mark作者: Hay-Fever 時間: 2025-3-25 00:59
Post-Market Surveillance and Vigilance on the European Market,ative environment contribute to the fact that a product initially approved as “safe and effective” leads to complaints, to malfunctions, and, in the worst case, to a safety risk for users, patients, or the general public. For this reason, it is necessary that manufacturers of medical devices and in 作者: Ingredient 時間: 2025-3-25 05:23 作者: Heterodoxy 時間: 2025-3-25 08:08
Robert Neubauer,J?rg Schr?ttner,Christian Baumgartner interaction is analyzed with the help of Monte Carlo calculations on a rotational isomeric state model. Attempts to fit the chain length dependence of the exchange interaction with a through-space model were unsuccessful. A satisfactory model does include through-bond interaction for the shorter ch作者: 表皮 時間: 2025-3-25 12:15
Johann Harerith frozen sections, fixed for instance in acetone. Alcohol or Bouin fixation followed by paraffin embedding also gives generally good results, although the long-term preservation of the material is less good. Formalin fixed and paraffin embedded material can be successfully applied in many instance作者: prosthesis 時間: 2025-3-25 17:03
B. Gübitz,U. Klingerith frozen sections, fixed for instance in acetone. Alcohol or Bouin fixation followed by paraffin embedding also gives generally good results, although the long-term preservation of the material is less good. Formalin fixed and paraffin embedded material can be successfully applied in many instance作者: abracadabra 時間: 2025-3-26 00:03 作者: 大笑 時間: 2025-3-26 01:02 作者: 熱心助人 時間: 2025-3-26 05:20 作者: 半導(dǎo)體 時間: 2025-3-26 09:01
Andrej Smogavc Cestar,Johann Harerthe mechanistic sense such a surface must not necessarily have a descend (almost degenerate catalyes such as olefin metathesis, H/D-scrambling, some olefin isomerizations), for a productive catalysis there should of course be a declining slope with the reaction coordinate. In the following paragraph作者: Popcorn 時間: 2025-3-26 14:43 作者: analogous 時間: 2025-3-26 18:30
Johann Harer,J?rg Schr?ttners for the presence of proteins homologous to growth factors, growth factor receptors, or protooncogenes. It is now clear that many of these proteins have been well conserved during evolution and are found in three organisms eminently suited to genetic manipulation—yeast, ., and ..作者: 一再煩擾 時間: 2025-3-26 22:03 作者: JOT 時間: 2025-3-27 01:26 作者: neutrophils 時間: 2025-3-27 06:51
Marie-Astrid Haibl,Clemens Borkenstein perform important cellular functions. Because Friend virus lacks such a modified cellular gene and contains only retroviral-specific nucleic acid sequences, and because it induces a progressively developing neoplasm rather than an immediate cancer, it has been widely assumed that it is relatively “作者: 喚起 時間: 2025-3-27 10:04 作者: 橫條 時間: 2025-3-27 16:32 作者: debouch 時間: 2025-3-27 20:56 作者: MEET 時間: 2025-3-27 22:14
Johann Harer has made great advances in recent years. My original intention was to write a single-volume textbook cov- ering most of the fundamental concepts and applications of optical signal processing. However, it soon became apparent that the large amount of material to be included would make publication in a single 978-3-642-74964-3978-3-642-74962-9作者: FLIP 時間: 2025-3-28 03:18 作者: 蝕刻 時間: 2025-3-28 06:48
2731-0493 resses medical manufacturing companies, professionals in?development, production, and quality assurance departments, and?technical and medicalstudents who are preparing themselves for a professional career in the medical technlogy industries.?.978-3-030-98743-5作者: Jogging 時間: 2025-3-28 13:29 作者: deriver 時間: 2025-3-28 16:57 作者: 相反放置 時間: 2025-3-28 22:09
Medical Device Development,rocesses in the development phase as well as on effort allocation of resources during the development. Some supporting processes to the development process are also mentioned to give a holistic picture of what to consider when developing a medical device.作者: 受人支配 時間: 2025-3-29 01:32 作者: Biomarker 時間: 2025-3-29 04:35 作者: Galactogogue 時間: 2025-3-29 08:37
A Regulatory Guide for Medical Device Start-Ups in Europe: Challenges and Pitfalls,m other countries. The regulation introduces new requirements for the development and marketing of medical devices as well as increases the minimum requirements of already existing standards. While medium-sized and larger corporations are already partially struggling with the new situation, newly fo作者: Epidural-Space 時間: 2025-3-29 15:04 作者: fluoroscopy 時間: 2025-3-29 16:54 作者: 混亂生活 時間: 2025-3-29 20:38
Risk Management for Medical Devices in Compliance with EN ISO 14971, example, it is important to know from the outset which regulations or legal bases apply to risk management. For the implementation of the risk management process, it is important to know which phases it has to go through and which methods and tools are helpful in the implementation. And, of course,作者: 值得 時間: 2025-3-30 03:29 作者: Delirium 時間: 2025-3-30 06:21
Clinical Evaluation and Clinical Investigations of Medical Devices Under the MDR,ical devices (MDs) in the field. This concerned a lack of clear-cut processes, including planning and reporting, and even a lack of sufficient clinical data based on clinical investigation of high-risk MDs, and also the long-term clinical assessment of high-risk devices, like implants needed specifi作者: 駭人 時間: 2025-3-30 11:28
Performance Evaluation and Performance Studies of in Vitro Diagnostic Medical Devices Under the IVDmportance for most medical disciplines, including for medical genetic testing, prediction, staging or diagnosis of cancer, or proper microbiological diagnosis. This holds true for individual as well as public health relevant diagnosis and covers both professional and lay use. It is therefore importa作者: Acclaim 時間: 2025-3-30 15:28
Mastering Quality System Audits and Inspections for Medical Devices,their intended purpose and they shall not compromise the clinical condition or the safety of patients, the safety and health of users, or where applicable, other persons (MDR 2017/745). In order to achieve this, manufacturers of medical and in vitro diagnostic medical devices must have, in accordanc作者: 沉思的魚 時間: 2025-3-30 17:54 作者: 多嘴 時間: 2025-3-31 00:03 作者: 敲詐 時間: 2025-3-31 03:56
Medical Device Development,r begins with an introduction of regulatory requirements from a European and US perspective, covering the relevant international requirements during development. This is followed by a conceptional development model with user needs, design input, design output, and verification and validation through作者: 無力更進(jìn) 時間: 2025-3-31 09:00 作者: 冬眠 時間: 2025-3-31 10:09
GMP-Compliant Design for Plants Manufacturing Medical Devices,edical device, it starts with a short definition and explains the legal differences..As the field of medical devices is much more diverse than the definition of a medicinal product, there are only very general recommendations mentioned in the various legal documents. This chapter focuses on a specif作者: GLARE 時間: 2025-3-31 14:07 作者: Gene408 時間: 2025-3-31 19:11 作者: 斜坡 時間: 2025-4-1 00:53 作者: 退出可食用 時間: 2025-4-1 04:47 作者: 牛的細(xì)微差別 時間: 2025-4-1 07:05 作者: 單色 時間: 2025-4-1 12:52
J?rg Schr?ttner,Christian Baumgartnertutes the very first treatise on biomechanics. The author, Giovanni Alfonso Borelli (1608 - 1679), was professor of mathematics and physics in Pisa where he worked with Malpighi, who was professor of theoretical medicine and focused Borelli‘s interest on the movements of living creatures. This was t作者: LATER 時間: 2025-4-1 16:55 作者: 安撫 時間: 2025-4-1 18:31 作者: 混合,攙雜 時間: 2025-4-2 00:33
B. Gübitz,U. Klingerclonal antibodies with well defined specificities has greatly increased the potentially obtainable information from routine biopsy specimens. Basically, the only limiting factors for the demonstration of the presence of any biologically significant, antigenic molecules are the specificity of the ant作者: Anterior 時間: 2025-4-2 03:41
Elizma Parry. Dazu scheint diese Haltung besonders geeignet. Durch die direkte Kraftübertragung des Rumpfs über die Sitzbeinh?cker auf die Sitzfl?che werden die Beine entlastet. Bei Benutzung einer Lehne kann zus?tzlich Gewicht des Rumpfs auf das Sitzger?t übertragen werden. Dadurch ist eine Minderbeanspruchung作者: 舉止粗野的人 時間: 2025-4-2 07:21
Wolfgang Eckeriege. Zun?chst ist dies eine Frage der lokalen Durchblutung. Die Drucktoleranz des Gewebes ist begrenzt. Allein aus diesem Grunde werden beispielsweise gef?hrdete Patienten auf der Intensivstation zur Dekubitusprophylaxe Tag und Nacht in 3stündigem Wechsel umgelagert. Das st?ndige Wechseln der K?rpe作者: MULTI 時間: 2025-4-2 13:27
