The Advanced level of the Aleph Quality Management Systems for Medical Devices course track is for professionals who already have the QMS framework covered at orientation depth and need to develop the applied skills the medical-device industry expects: authoring a Manufacturing Quality Control Plan and an Inspection Test Plan derived from a Process FMEA; authoring a Material Review Board procedure for non-conforming-product disposition; producing a Design and Development Plan consistent with ISO 13485 §7.3 and 21 CFR §820.30; applying the ISO 14971 process to identify hazards and rank severity and probability; developing an internal audit calendar covering both ISO 13485 and 21 CFR Part 820; completing a Customer Complaint record and deciding Medical Device Reporting reportability under 21 CFR Part 803; and authoring a Supplier Audit Plan under ISO 13485 §7.4.

This 32-hour Professional Certificate Course builds directly on the 16-hour Introductory level (`RAQ-520-I`). It does not repeat the framework material. Where the Introductory level identifies the Manufacturing Quality Control Plan as a document, the Advanced level authors one for a chosen product. Where the Introductory level identifies CAPA, the Advanced level constructs a complete defensible CAPA record. Where the Introductory level identifies Medical Device Reporting at orientation depth, the Advanced level makes a defensible reportability decision under 21 CFR Part 803 on a real complaint. The course organizes its applied work explicitly around the four FDA subsystems — Production and Process Controls, Design Controls, Management, and CAPA — and culminates in a final assessment that exercises cumulative working QMS command.

Graduates of the Advanced course are positioned for senior applied work in quality, regulatory, and audit roles at medical-device manufacturers, at contract manufacturing organizations, and at consultancies supporting QMS implementations and inspection readiness. The authored MQCP, ITP, MRB procedure, D&D Plan, Process FMEA, CAPA record, internal audit calendar, Customer Complaint record, and Supplier Audit Plan produced during the course are portfolio-grade artifacts.

Participants who meet the course completion requirements receive a Certificate of Completion issued by Aleph University.