About AcmeBiotechs Consulting Inc.
AcmeBiotechs Consulting Corp. founded in September 2008 by Mr. Hsienkun Lee. We focus on provide services on regulatory consulting, quality assurance system counseling, and device registration exclusively to medical device industries. Through effectively and accurately complying regulations in different countries, our clients are able to legally commercializing their products in their targeted foreign markets without concerns. We support and help our clients to expand their business in the globalized medical device market. Especially, we have abundant experience to assist and expedite foreign companies to explore and enter potential and fast growing Greater China market.
We take clients as our center and focus on helping them to comply medical device regulations of many counties. Therefore, clients can minimize required time on developing products and preparing on entering new markets. By paying particular attentions to quality, science, and efficiency, we strictly demand on conforming medical device regulation in high international standard.
AcmeBiotechs cooperates closely with certification institutions and testing laboratories to support our clients to acquire any necessary technical reports and tests during the FDA 510(k) verification process. Tests and reports include design control, biocompatibility, electromagnetic compatibility (EMC), pre-clinical study, sterilization validation, software validation, clinical evaluation, substantial equivalence, and others.
We take clients as our center and focus on helping them to comply medical device regulations of many counties. Therefore, clients can minimize required time on developing products and preparing on entering new markets. By paying particular attentions to quality, science, and efficiency, we strictly demand on conforming medical device regulation in high international standard.
AcmeBiotechs cooperates closely with certification institutions and testing laboratories to support our clients to acquire any necessary technical reports and tests during the FDA 510(k) verification process. Tests and reports include design control, biocompatibility, electromagnetic compatibility (EMC), pre-clinical study, sterilization validation, software validation, clinical evaluation, substantial equivalence, and others.
