RAS633

Introduce the overarching process and pathway for global medical device clearance/approvals.

Examine the purpose of quality systems and standards; explain the history and impact on product and public safety over time as well as the importance of quality products from the perspective of healthcare providers (clinical use as well as product performance).

Describe US quality system requirements (QSR)/EU quality management system (QMS) requirements throughout the product lifecycle.

Analyze and identify the differences, similarities, and interdependencies between QSR/QMS requirements and standards applicable to support the development, manufacturing and monitoring of healthcare products.

Determine the interactions between professionals and regulatory bodies.

Interpret and address Quality System inspection questions and observations related to the manufacturer of medical products.

Analyze and respond appropriately to regulatory communications and questions with clear and concise technical responses.