Practical Design Control Training for Medical Device Teams

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What You’ll Gain

By the end of this course, you will be able to:

Navigate design control requirements under QMSR and ISO 13485:2016
Implement a structured design control process from concept through transfer
Define intended use, indications for use, and user needs more effectively
Write measurable design inputs that support verification and validation
Build traceability between user needs, design inputs, outputs, and testing activities
Conduct documented design reviews with cross-functional participation
Distinguish verification from validation and understand when each applies
Evaluate design changes for regulatory impact and risk management implications
Maintain documentation that supports audit readiness and regulatory inspections

What’s Included

Five focused training modules

Step-by-step lessons covering the design control process, design phases, traceability, verification and validation, transfer activities, and design change control.

Practical development workflow

Follow the progression of a medical device from concept planning through commercialization using real-world design control examples.

Regulatory and QMSR-focused guidance

Clear explanations of design control expectations under QMSR, ISO 13485:2016, and related FDA quality system requirements.

Traceability and documentation strategies

Learn how to structure trace matrices, design reviews, and supporting records that demonstrate a complete and defensible design history.

Verification, validation, and transfer insights

Understand how testing activities, design freeze, and transfer planning fit together within the broader development process.

Design change control framework

Learn how to assess design modifications, document regulatory impact decisions, and integrate risk management into change evaluations.

Knowledge check and certificate

Validate your understanding through a course quiz and receive a certificate of completion.

One year of access

Revisit the course materials anytime while supporting development projects, updating procedures, or preparing for audits.

Who This Course Is For

On-Demand Video Lessons – Expert-led training covering QMSR structure, design controls, supplier management, CAPA, and compliance strategies.
Templates and Cheatsheets – Essential regulatory documents, including audit checklists, CAPA templates, and QMS roadmaps.
Downloadable Resources – Practical guides on QMSR requirements, FDA inspection preparation, and ISO 13485 alignment.

This course is designed for:

Quality Assurance professionals
Regulatory Affairs specialists
Design and development engineers
Medical device project teams
Quality and compliance personnel supporting product development

Build a stronger, more defensible design control process.