ABSTRACT
Successful medical product design follows a proven process that complies with the applicable regulatory standards. ISO 13485 requires that a comprehensive management system be established and maintained to monitor and control/mitigate risks from product inception through design transfer and into production, referred to by the FDA as total product life cycle (TPLC). There are various stage gate reviews during the TPLC with the manufacturing readiness review being the nal gate for the design transfer to production.
