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Angela Bazigos CEO, Touchstone Technologies Silicon Valley What is the substantiation standard and the elements that determine the amount and kind of substantiation for claims Conclusion To expedite the process of bringing a product to market through the 510(ok) program, it is crucial the medical system makers perceive the recent modifications and be capable of submit a 510(k) to successfully clear it.
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Telephone: 800-447-9407 Fax: 302-288-6884 Many companies know that a written response is required when the company is issued a 483 by FDA, but they have no idea or perceive … Read More