At present, the frequency of update in the regulations, guidelines and standards related to medical devices has been greatly increased, and the supervision has become increasingly strict. Our team brings together regulatory, medical and clinical experts in various fields to help you take the lead in compliance.
Regulation and standard interpretation/input at product development stage
Pre-market registration strategy assessment
Difference analysis of domestic and foreign standards
Modification Registration/Filing strategy
Change strategy of IFU and label
Mandatory standard update and product renewal strategy
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