Getting you regulation, compliance and technical filing completed underpins all previous phases, drawing heavily on the design controls, validation data and manufacturing information. It culminates in the filings required for preparation for product launch and continues with post-market vigilance and reporting.
Activities in this phase include compiling the technical file/design dossier, preparing regulatory submissions (e.g., 510(k), PMA, CE marking), interacting with regulatory bodies, and establishing post-market surveillance procedures.
Read the accompanying Waypoints below for more guides and help on regulation, compliance and technical filing.
