Be Ready for FDA-Inspected Management Reviews by February 2026

Learn exactly how to structure, document, and execute your management review to meet every QMSR and ISO 13485 requirement.

What You’ll Gain

A Proven Structure: Conduct reviews that meet every QMSR and ISO 13485 requirement.
Audit-Ready Templates: Create records that demonstrate leadership engagement and decision-making.
Clear, Actionable Process: Know exactly what to review, who should attend, and how to follow through.

Confidence in Compliance: Ensure your team and leadership are prepared for FDA inspections.

What’s Included

Four self-paced video lessons covering regulatory expectations, preparation, execution, and follow-up.
A 10-question knowledge quiz to confirm understanding.
A completion certificate for training records.
One year of access to all materials — download everything for future reference.

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.

MedTech regulatory and quality leaders
Management representatives
QMS coordinators and auditors
Anyone responsible for planning or facilitating management reviews

The LeanRAQA team brings decades of hands-on experience in MedTech quality systems, regulatory compliance, and audit readiness. Our guidance is informed by current FDA expectations and international best practices.

Enroll Today

and have your process audit-ready before your next management review.