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  • Medical Device Link . General Aging Theory and Simplified Protocol for Accelerated Aging of Medical Devices
    , ambient-aged samples usually do not exist for a such products, it is generally necessary to conduct accelerated-aging tests to provide experimental data in support of performance and shelf-life claims for these products until full-period samples become available. The ability of product designers to accurately
  • Medical Device Link . Biostatistics and the Analysis of Clinical Data
    Medical Device & Diagnostic Industry Analysis of the data from a medical device clinical trial or study is one of many critical steps along the path to FDA approval and, ultimately, to the marketplace. It is the culmination of all prior planning and execution of the study protocol. In the course
  • AN-00160 - Considerations for Sending Data Over a Wireless Link
    Except for the encoder/decoder pair, Linx modules do not place any constraints on the type or format of the data being sent. This freedom allows for more versatility in the types of applications that can use the modules, but it also places the protocol design burden on the customer
  • Medical Device Link .
    the use or necessity of a physical connection. Of primary importance to the medical device designer trying to assemble a wireless link is an estimation of the data rate and data range of a low-power, low-data-rate radio. Fortunately, there are a few simple equations that can help provide a practical
  • Medical Device Link .
    20 companies, some of which have integrated the CAN module with a microcontroller. Because CAN is a data-link-layer protocol, it specifies only basic communication services. Users must specify an application layer and a communication profile, which defines the use of identifiers, configuration
  • Medical Device Link .
    with inclusion and exclusion criteria, and treated as specified by the protocol. Finally, planning is required for management and monitoring of the study, including requirements for recording adverse events, and management of the data generated during the study. These steps should be conducted in accordance
  • Medical Device Link .
    its medical business while pursuing new customers. Its recently developed product realization package (PRP) offers flexible, custom-tailored process optimization, which touches on details associated with part, mold, process, and quality data. The PRP program complements ISO 9000:2000 and expedites
  • Medical Device Link .
    Wireless Medical Devices: Satisfying Radio Requirements Understanding radio protocols and requirements is the first step in successfully using wireless communication in medical applications. A wide variety of medical applications, such as implantable devices and telemetry equipment
  • Medical Device Link .
    with third-party applications and networks. For example, a picture archiving and communication system (PACS) image database manager might be layered right onto the acquisition instrument that feeds directly into the user's standard communication protocol to exchange data files (such as patient records
  • Medical Device Link .
    realisation. " The spirit of the standard demands that the organisation plan and develop the processes needed for product realisation and that it be consistent with the requirements of all processes in a quality management system. Most moulders use inspection data, capability studies, and traditional
  • Medical Device Link .
    submitting a PMA or a 510(k) notice. (FDA's much-ballyhooed product development protocol is rarely considered a viable alternative.) If a clinical study is required, however, the IVD manufacturer has three choices: an IDE study, a nonsignificant risk study, or a study that is entirely exempt from the IDE
  • Medical Device Link . Design considerations for IVD clinical trials:
    Cheryl L. Hayden and Michael L. Feldstein An IVD clinical trial represents a major investment for the sponsoring company; consequently, it is important to maximize the utility of the trial. One way to accomplish this is to design the trial protocol to include several time-staggered end points
  • Medical Device Link . Industry Responds to Pyronema domesticum: HIMA Screening Studies Contamination of imported and domestic cotton products prompts investigation into effectiveness of EtO sterilization.
    : to provide a relatively simple protocol that manufacturers could use to detect the presence of on their products, and to provide a consistent method that could be used to collect data to answer questions about the prevalence of in cotton. As stated in the
  • Controls target M2M
    New hardware and software from Opto 22 uses the familiar Internet Protocol (IP) to link machine processes such as sensor and production data with enterprise software. New hardware and software from uses the familiar Internet Protocol (IP) to link machine processes such as sensor and production data
  • Selecting an MCP21XX Device for IrDA (R) Applications
    be implemented in each embedded systems firmware to address data integrity and the communication link.
  • A CAN Physical Layer Discussion
    Many network protocols are described using the seven layer Open System Interconnection (OSI) model, as shown in Figure 1. The Controller Area Network (CAN) protocol defines the Data Link Layer and part of the Physical Layer in the OSI model. The remaining physical layer (and all of the higher