In order to provide sterile medical device and Exempt from the patient' s infection from each other, medical devices must be disinfected strictly. However, the disinfection may affect by many aspects....
Osmunda Medical Device Consulting Organization ( Guangzhou, Beijing, Shanghai, Suzhou, Shenzhen and Jinan) is the largest and most professional consulting company in this industry in China. All....
Each medical device manufacturing enterprise must have a medical device manufacturing enterprise license, which is supervised and issued by local SFDA. Enterprises who want to obtain the license must....
In order to strengthen the management of IVD enterprises and make a standard for IVD reagent enterprise , National Bureau has drawn up the Acceptance Criteria of IVD Reagent and Acceptance Criteria....
` Benefits of the training Help enterprises make a better understanding on the specifications and regulations which are about requirements on special procedure conformation. Detail introduction....
Osmunda has successfully assisted nearly 1, 200 domestic and foreign enterprises in achieving various medical devices registration and certification. We will be your trustful partner and your most....
Currently in China, except the in vitro diagnostic reagents ( IVDD) which used for blood screening and adopting radioisotope labeling, other IVDD need to be managed as medical device ( MD) . IVDD is....
Services we provide: medical device registration consulting, ISO13485certification consulting, medical equipment certification consulting, FDA510K registration, the European CE certification....