The essential principles checklist should incorporate a cross-reference to the locati ...

(b) conformity with an in-house test method; (c) the evaluation of pre-clinical and c ...

Strategic Alliances-- ACPL provides market research on potential joint ventures, acqu ...

Distribution Channels Research: Understanding the most effective distribution channel ...

DEVICE MASTER FILE FOR MEDICAL DEVICES OTHER THAN IN VITRO DIAGNOSTIC MEDICAL DEVICE ...

INFORMATION TO BE SUBMITTED ALONG WITH THE APPLICATION 1. Design Analysis data inclu ...

INFORMATION REQUIRED TO BE SUBMITTED WITH THE APPLICATION FORM FOR IMPORT OR MANUFAC ...

(b) If the in vitro diagnostic medical device contains any of the following then desc ...