About AcmeBiotechs Consulting Inc.
AcmeBiotechs Consulting Inc. was founded in September 2008 by Mr. Hsienkun Lee, with a focus on providing services for regulatory consulting, quality assurance system counseling, and device registration exclusive to medical device industries. By effectively and accurately complying to regulations in different countries, our clients are able to confidently and legally commercialize their products in their targeted foreign markets. We support and help our clients in expanding their business in the globalized medical device market. In particular, we have abundant experience in assisting and expediting foreign companies into great potential in the fast growing Greater China market.
With clients always at the center, we focus on helping them comply with the medical device regulations in many countries. Therefore, clients can minimize the time required for both developing products and preparation for entering new markets. By paying particular attention to quality, science, and efficiency, we demand strict conformity to the medical device regulations in par with the high international standard.
AcmeBiotechs cooperates closely with certification institutions and testing laboratories to support our clients in acquiring 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.
With clients always at the center, we focus on helping them comply with the medical device regulations in many countries. Therefore, clients can minimize the time required for both developing products and preparation for entering new markets. By paying particular attention to quality, science, and efficiency, we demand strict conformity to the medical device regulations in par with the high international standard.
AcmeBiotechs cooperates closely with certification institutions and testing laboratories to support our clients in acquiring 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.