Analysis of data The manufacturer shall establish documented procedures to determine, ...

(3) If on receipt of the application and the report referred to in sub-rule (2), the ...

(vii) the registration holder shall inform forthwith, any change of existing expert ...

(d) records needed to provide evidence that the realisation processes and resulting p ...

7.7 Animal studies: (i) Where studies in an animal model have been undertaken to prov ...

(ii) Detailed information: Detailed information should include: (a) complete study pr ...

22.0 Information required to be submitted for the in vitro diagnostic medical device: ...

Our area of expertise varies from Compliance Certification ( BIS, WPC, EPR, CDSCO, Co ...