WHY TRAIN WITH VELOCITY 360?

Certified Provider.
Quality-Assured Training.

Velocity 360 training products are developed within our ISO 9001:2015 quality management system, certified by NQA, an ANAB-accredited certification body. We are also an Exemplar Global Certified Training Provider for select training programs.

Exemplar Global, NQA ISO 9001 and ANAB accreditation credentials

Course Curriculum

    1. How to use this course

    1. ISO 13485:2016 Quick Reference Guide

    2. ISO 19011:2026 Quick Reference Guide

    3. ISO 13485:2016 Audit Checklist

    1. ISO 13485-Lesson-02

    2. ISO 13485-Lesson-01 and 02-QUIZ

    1. ISO 13485-Lesson-03

    2. ISO 13485-Lesson-03-QUIZ

    1. ISO 13485-Lesson-04a

    2. ISO 13485-Lesson-04b

    3. ISO 13485-Lesson-04-QUIZ

    1. Video-Summary-Leadership requirements

    2. ISO 13485-Lesson-05

    3. ISO 13485-Lesson-05-QUIZ

ISO 13485:2016 Lead Auditor

  • $1,795.00
  • On Demand / Student-Paced
  • 32 hours / 3.2 CEUs
  • English
  • Exemplar Global Certified

Learning Objectives

  • Understand quality management definitions, concepts, and guidelines for ISO 13485:2016

  • Know the requirements of the ISO 13485:2016 standard

  • Understand the process approach

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What Learners Say

Feedback from professionals who completed Velocity 360 training.

5 out of 5

ISO 13485 Lead Auditor

Strong Case Studies and Self-Reflection

After 25 years in the industry, I was impressed by the case studies. I learned more about the industry and a great deal about my own audit style and methods.

Dana Lupo

5 out of 5

ISO 13485 Lead Auditor

Practical Auditing Scenarios

Great certification course, especially the final quizzes on real life scenarios using auditor judgment.

Jonathan Aldaba

5 out of 5

ISO 13485 Lead Auditor

Detailed Course with Valuable Downloads

Great course with sufficient detail. I loved the downloads and the content.

Darron Henderson

5 out of 5

ISO 13485 Lead Auditor

Easy to Understand

The course was good and easy to understand.

Izdham Musa

5 out of 5

ISO 13485 Lead Auditor

Thorough and Confidence-Building

The course was thorough and provided the information and guidance I needed to confidently conduct QMS audits.

Amy Keith

5 out of 5

ISO 13485 Lead Auditor

Thorough, Scenario-Based Auditor Training

The course was very thorough. I especially liked the many case scenarios that required applying the standard's concepts and deciding how they should be addressed during an audit.

Rebecca Campbell

5 out of 5

ISO 13485 Lead Auditor

Easy, Self-Paced Training

Great training, easy and self paced.

William Leiker

Earn a Verifiable Certificate of Competence

Secure, Digital, and Professionally Shareable

Successfully complete the course to receive a secure, digitally verifiable Certificate of Competence that can be independently validated and added to LinkedIn or another professional profile.
Enroll Now — $1,795 USD

Advance Beyond Lead Auditor Training

Choose the ISO 13485 Certified Quality Manager – Medical Devices program and receive the complete ISO 13485:2016 Lead Auditor course—plus ISO 14971 Risk Management, U.S. FDA QMSR, Good Documentation Practice and ALCOA+, and FMEA—culminating in the ISO 13485 Certified Quality Manager – Medical Devices credential.

Certified Quality Manager – Medical Devices program
Six
Certificates
48 Training
Hours
4.8 CEUs
Explore the Complete Program — $2,195 USD