✓ Certified Course ISO Management Systems

ISO 13485 Lead Auditor Course (Medical Devices QMS)

Become a certified lead auditor for Medical Devices Quality Management Systems aligned with ISO 13485.

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Accreditation
40 Hours (5 Days) Duration
Live Online Format
Certificate On Completion
Enrol Now — $350.00
ISO 13485 Lead Auditor Course (Medical Devices QMS)
Course Overview

About this course

This course develops the skills to audit a medical devices quality management system against ISO 13485, covering design controls, regulatory requirements, and risk management practices.
What's Included

Everything you get

✓ Live instructor-led sessions
✓ Downloadable templates and working documents
✓ Full learning management system access
✓ Realistic simulated audit case study
✓ Exam registration handled for you
✓ Digital certificate on successful completion
What You'll Achieve

Learning outcomes

OUTCOME 1

Explain the medical devices QMS framework and ISO 13485 requirements

OUTCOME 2

Audit design controls and regulatory compliance processes

OUTCOME 3

Plan, conduct, report and follow up a medical devices QMS audit

OUTCOME 4

Evaluate risk management and traceability practices

Skills You'll Gain

Practical, job-ready skills

Design control evaluation Regulatory compliance auditing Interviewing and evidence gathering Nonconformity writing and grading Audit reporting and follow-up
Career Outcomes

Where this can take you

Step 1

Internal QMS Auditor

Audit your organization's medical devices quality system.

Step 2

Medical Devices Lead Auditor

Lead certification audits for third-party bodies.

Step 3

Regulatory Affairs Manager

Oversee organization-wide regulatory compliance.

Curriculum

Course modules

1
Module 1: Medical Devices QMS Fundamentals & ISO 13485 Framework
2
Module 2: Audit Principles & Auditor Roles
3
Module 3: Design Control & Regulatory Review
4
Module 4: Conducting the Stage 2 Audit
5
Module 5: Auditing Risk Management & Traceability
6
Module 6: Nonconformities & Reporting
7
Module 7: Closing Meetings & Corrective Action
8
Module 8: Auditor Ethics & Programme Management
How You'll Learn

Format & delivery

✓ Live virtual instructor-led sessions
✓ One continuous case study audited end-to-end
✓ Choice of intensive or part-time schedule
Assessment & Certification

How you're assessed

Assessment is continuous through in-course activities, plus a final objective examination lasting approximately 1 hour 45 minutes, open book. Your first exam attempt is included in the course fee. A certificate is issued shortly after a passing result.
Is This Course For You?

Who should attend

  • Medical device quality managers
  • Regulatory affairs professionals
  • Internal auditors moving to certification auditing
  • Professionals pursuing medical devices QMS lead auditor certification
Answers

Frequently asked questions

What does this course cover? +
ISO 13485 requirements, design controls, and auditing medical device quality management systems.
Who should attend? +
Medical device quality managers and regulatory affairs professionals.
Is regulatory knowledge required? +
Basic regulatory awareness is helpful; the course covers requirements in detail.
What prior knowledge is recommended? +
Basic familiarity with quality management concepts is helpful but not required.
How is the exam conducted? +
Online, open book, with objective questions.