21 CFR Part 820

The Quality Management System Regulation – Product Realization

In this course, learners step into the shoes of the fictional team to see how the QMSR serves as the invisible architect of safety. They trace the life of a product from its first blueprint to the moment it leaves the sterile pouch, ensuring that for this patient, and every patient, failure is not an option.

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CEU Credits: 0.1
Course Code: ELM-818
Duration: 15 mins
Skill Level: Intermediate
Final Exam: Yes
Certification: Yes
Version: v1.0
Effective Date: 03/31/2026

Curriculum for this course

Failure is not an option
Product realization under the QMSR
From concept to customer: an overview
Product realization planning
Planning the Neuro-Valve
Determination of requirements
Review of requirements
Neuro-Valve requirements
Planning, inputs, and outputs
Neuro-Valve planning, inputs, and outputs
Design review, verification, and validation
Design transfer
The Design and Development File: Replacing the DHF
Risk-Based supplier evaluation and monitoring
Purchasing information and verification
Purchasing at P.C. Ruth Medtech
Process controls and validation
Identification and Traceability
Neuro-Valve identification and traceability
Preservation of Product
Calibration and Verification
Out of calibration
Summary
Test Your Knowledge
v1.0 | Course released on 11/24/2026

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