Medical Device Compliance Training for Management covering the quality and regulatory requirements of ISO 13485 (Medical Device Standard) and 21CFR 820 (FDA Quality System Regulation). The training covers all clauses of both regulations focused on providing trainees will an in-depth understanding on the medical device quality system requirements. Coverage areas include: Planning, Design, Manufacturing, Inspection, Testing, Post Market Surveillance, Risk Management, Process Validation, Documentation, Records, Training, Maintenance, Supply Chain Controls, Leadership / Management requirements, etc.
