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All of the risk analysis tables, the risk control measures, verification results, risk/benefit analyses, risk evaluations, and traceability analyses need to be documented and available for inspection by auditors. One way to organize this documentation is to have a risk management file that includes or references each of these documents.
Abstruct-The predominant method for pain management is medication. One very different approach to pain management is the application of micro-to milliamp current applied to specific areas of the head. While this may sound like a novel concept to most of us, years of research indicate that transcranial electrotherapy stimulation (TES) can work to… (More)
Results of a randomized, double-blind pilot study indicate that transcranial electrotherapy stimulation may be an effective treatment for the temporary reduction of pain in osteoarthritis patients. Presently, the predominant method for pain management is medication. One very different approach is the application of micro- to milliamp current applied to… (More)
For new and innovative medical devices, a company is most likely to have direct communications with the FDA at some course during the product lifecycle. Most often these are meetings relating to what type of information is required in the marketing application (510(k) or PMA) and discussions relating to approval of the device. This session will explore the… (More)
This discussion group will explore the different requirements for getting a medical device cleared for marketing in the United States. Specifically, the discussion leaders will give an overview of the 510(k) and PMA, registration, and listing processes. The discussion will also include what is required for foreign companies who wish to import medical… (More)