Study medications/devices control

Control of study medications/devices The product being studied must be managed so that study subjects ultimately receive a safe product and full accountability can be documented Archives Documentation of research activities must be securely retained to provide evidence of activities... 

Control of study medications/devices at study sites... 

Control of Study Medications/Devices at Study Sites... 

Medical devices used to take chnical trial measurements must comply with medical device regulatory requirements. These cover design controls and software validation.Another case study in this book deals with medical device validation (see Chapter 40 Case Study 22). 

There is no doubt tliat the field of electrochemistry and its continual progress can and will have a substantial impact on the future of medical devices. Devices continue to be scaled down in size, which will necessitate a greater understanding of corrosion processes. As analytical tools for the study of surface chemistry improve and become more widespread, and as nano-architectmed control permeates into the medical world, electrochemistry will be viewed as an economical, simple, yet powerful technique to modify and create biomimetic surfaces and medical devices. 

Li, D. Guo, G. Fan, R. Liang, J. Deng, X. Luo, F. Qian, Z. PLA/F68/Dexamethasone implants prepared by hot-melt extrusion for controlled release of anti-inflammatory drug to implantable medical devices I. Preparation, characterization and hydrolytic degradation study. Int. J. Pharm. 2013,447(1-2), 365-372. 

Safety of software is equal in importance to that of the hardware elements, as consequences of a software failure in medical devices can be quite serious. For example, a program that is out of control because of a software error can drive a radiation therapy machine gantry into a patient [9]. A Food and Drug Administration (FDA) study conducted over six years (1983-1989) reported that there were 116 problems in software quality that resulted in the recall of medical devices in the United States [3]. Most of the methods and techniques that can be used to improve software safety in medical devices are available in Refs. [10-12]. 

Self-assembled monolayers (SAMs) of alkanethiolates on metal surfaces constitute a class of molecular assemblies formed by the spontaneous chemisorption of long-chain functionalized molecules on the surface of solid substrates. Due to their ease of preparation, long-term stability, controllable surface chemical functionality, and high, crystal-like, two-dimensional order, SAMs represent suitable model surfaces to study molecular adsorption, adhesion, wetting, lubrication, and the interaction of proteins and cells with artificial organic surfaces. The latter phenomena are of crucial importance to the fields of biomaterials, biosensors, and medical devices. 

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