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Medical Standards List

Staying up to date requires a lot of time and effort when you are working in the medical devices industry. You need first to select the proper source of information then filter to match with your product category. Finally you only can guess which standard could be appropriate. Medical Standards List is a new service…

Technical document review in South Korea

Technical document review A technical document review is a general “technical document review” (TDR) for those products that are basically the same as an already approved product, whereas a “safety and efficacy review” (SER) is required for devices unlike those currently available on the market – falling under new structure, new performance, new intended use,…