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ISO 13485 Overview Training for Medical Device and IVD Manufacturers

If your organization is part of the medical device supply chain and you are considering gaining ISO 13485:2016 certification or are new to ISO 13485 and want to understand the requirements, this is a must-take class. These foundational courses dig into several important clauses of ISO 13485:2016 including those related to product realization, customer-related processes, design and development, purchasing, complaint handling, monitoring, corrective actions and more. We also offer ISO 13485 internal auditor and lead auditor classes. 

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We Offer Two ISO 13485 Overview Training Classes. Which One is Right for You?

SkillsLab Class ?
DaySmart Class ?

Class Content

In-Depth

Foundational Overview

Class Duration

4 Half-Day Sessions*

6 Hours (One Day)

Teaching Format

Live, Instructor-Led

Live, Instructor-Led

Delivery Options

Virtual or In Person**

Virtual or In Person**

Certification of Completion

Yes

Yes

Continuing Education Units (CEUs)

1.6

0.6

* SkillsLab classes delivered in-person are full-day sessions delivered over 2 consecutive days. 

** Interested in private training for your team, virtually or in-person at your facility? Ask us about it!

Upcoming Classes

Upcoming ISO 13485:2016 Training Classes

SkillsLab $2195 DaySmart $995

SkillsLab $2195

There are no public training classes scheduled right now but this class can be delivered privately to 6 or more people at any time. Ask us for details!

DaySmart $995

Course Code Location Class Begins Class Ends Daily Schedule Course Delivery Class Agenda Registration
QSD VIRTUAL DELIVERY (Eastern Time) 18 Feb 2025 18 Feb 2025 10:30AM - 5:30PM Eastern US Time Virtual REGISTER
QSD VIRTUAL DELIVERY (Eastern Time) 16 Jun 2025 16 Jun 2025 10:30AM - 5:30PM Eastern US Time Virtual REGISTER
QSD VIRTUAL DELIVERY (Eastern Time) 02 Sep 2025 02 Sep 2025 10:30AM - 5:30PM Eastern US Time Virtual REGISTER

GROUP DISCOUNT

Save up to

25%

Register 3 people, 4th attends free!

Free

*This offer cannot be combined with any other promotional offer(s).

Course Overview

ISO 13485 Training: How Deep Do You Need to Go?

Our DaySmart option provides a foundational overview of ISO 13485:2016. You’ll walk away with a solid understanding of the essentials of compliance. Our SkillsLab class goes deeper into more areas of the standard, with additional hands-on exercises to apply your knowledge. See the table below and choose the option that fits your needs.

 

Course Overview
SkillsLab Class
DaySmart Class

Quality Management Systems

  • Evolution of ISO 13485
  • International medical design regulations

Medical Device Overview

  • Define medical devices
  • Risk, classification, intended use
  • Regulations and certifications

ISO 13485 Evolution

  • Relationship to ISO 9001
  • Change drivers
  • Auditing to 13485:2016
Exercise!

ISO 13485:2016 Introduction

  • Introduction, Part 1
  • Terms and definitions

ISO 13485 Requirements - Clauses 4 and 5

  • Clause 4 - Quality Management System
  • Clause 5 - Management Responsibility
Exercise!

ISO 13485 Requirements - Clause 6, 7, 8

  • Clause 6 - Resource Management (DaySmart focuses on 6.3 and 6.4)
  • Clause 7 - Product Realization (DaySmart focuses on 7.1-7.6)
  • Clause 8 - Measurement, Analysis and Improvement (DaySmart focuses on 8.1-8.5)
Exercise!

ISO Registration and Compliance

  • Implementation
  • Certification
What You Will Learn

What You Will Learn

At the conclusion of this training class, you will be able to
SkillsLab
DaySmart

Understand the requirements of ISO 13485:2016.

Apply process-based thinking to an ISO 13485-compliant quality management system.

Understand what is and is not a medical device, and how medical devices are classified and regulated. 

Establish the relationship of ISO 13485 to ISO 9001 and the FDA Quality System Regulation 21 CFR 820. 

Review the QMS requirements in the ISO 13485:2016 standard. 

Plan the activities of a registration audit. 

Understand ISO 13485 Product Realization requirements in Clause 7.

Undersand Measurement, Analysis and Improvement requirements in Clause 8. 

Who Should Attend

Who Should Attend

This course is appropriate for anyone who needs to know how to meet the requirements of ISO 13485, including management team members; RA/QA staff; internal auditors; compliance and legal; product, project, and program managers; R&D or engineering managers; and other cross-functional team members.

  • Engineering Managers
  • RA/QA Managers
  • Executives New to Devices
  • Research & Development
  • Compliance and Legal 
Related Courses & Services

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