Regulatory Services to obtain Device Registration with Health Canada

Client Type: Medical Device

Jurisdiction(s): Canada

Services Provided: Discussed strategy for MDL & MDEL in connection with supplier. Performed a conformity assessment procedure review to ISO 13585:2016. Reviewed certification, finalized labeling/product health claim, risk classification, and submitted a Class II Medical Device application. Label conformity, SOP structure/approval, inspection hosting, CAPAs, MDEL.