This was since Singapore and Eire, if I recall properly, got so many various/conflicting "interpretations". Streamline your documentation processes and recordkeeping protocols by maintaining all compliance studies in SafetyCulture’s safe cloud storage. Phase 2 (Primary Audit) – This is where you ensure that the rest of the ISO 13485 certification https://www.nathanisoconsulting.com/iso-22301-business-continuity-usa.htm