we are a global consulting organization for medical, biotechnology, and in vitro diagnostic devicecompanies in iso 13485 and cmdcas registration preparation, ce marking, part 11 and software 510(k)s, and international registrations.
검색 하기 키워드:
iso 13485, cmdcas, ivd directive, 510(k), en 60601-1-4, 21 cfr 11, 21 cfr 812, 21 cfr 820, part 11, eu authorized representative, fda us agent, technical files, quality systems, safety testing, 93/42/eec, 98/79/ec