ISO 13485 Foundation Training is for anyone looking to gain a comprehensive understanding of the core requirements of ISO 13485 and this highly interactive course can be completed anytime, anywhere (24/7).

Our online training is a highly interactive way to learn at a time & a pace that works best for you, making it easier to get the training you need while balancing a busy home or work life.

Why Comply Guru?

  • CQI & IRCA Certified Training (No. 2415)
  • Self-Paced, On-Demand Learning (24/7)
  • Highly Interactive, Engaging Experience
  • Industry-leading Methodology
  • Designed by Experts with Proven Expertise
Course Snapshot
Accreditation
CQI & IRCA (No. 2327)
Duration
8hrs
Available Format
eLearning
Price
EUR €  495.00
Learner Rating
★★★★★ 487 Reviews

Course Overview

ISO 13485 Foundation Training

Learning Objectives Covered

Explain the purpose of a medical device quality management system, of medical device quality management systems standards, and the business benefits of improved performance given by an effectively implemented medical device quality management system

Outline the structure and content of ISO 13485 and its relationship with ISO 9001 and IMDRF individual country regulatory documents

Explain the specific quality management-related requirements of ISO 13485

What This Course Covers

A summary of learning topics within this course include:

  • Purpose, Benefits & Structure of ISO 13485
  • Key Terms & Definitions
  • Principles of Quality Management
  • Relationship with ISO 9001
  • Key Concepts (PDCA, Process Approach, Risk Management)
  • QMS Processes
  • QMS Documentation
  • Document Control
  • Record Control
  • Role of Top Management (Commitment, customer focus, quality policy, quality objectives, change control)
  • Responsibility
  • Authority and Communication
  • Management Review
  • Resource Planning
  • Purpose, Benefits & Structure of ISO 13485
  • Key Terms & Definitions
  • Principles of Quality Management
  • Relationship with ISO 9001
  • Key Concepts (PDCA, Process Approach, Risk Management)
  • QMS Processes
  • QMS Documentation
  • Document Control
  • Record Control
  • Role of Top Management (Commitment, customer focus, quality policy, quality objectives, change control)
  • Responsibility
  • Authority and Communication
  • Management Review
  • Resource Planning
Who Should Attend

This course is targeted at:

    • Quality Managers
    • Quality Professionals/Technicians
    • Quality Engineers
    • Procurement Personnel
    • Financial Personnel
    • Document Controllers
    • Internal Auditors
    • Owner Managers
    • Implementation Members
Course Accreditation & Certificate

CQI IRCA

CQI & IRCA certify this course (No. 2327). Upon successful completion, each Learner shall receive a digital Certificate of Completion within 1 business day.

What Are The Entry Requirements

It is recommended that each Learner should have the following prior knowledge before completing this course:

  • The Plan, Do, Check, Act (PDCA) cycle
  • The core elements of a management system and the interrelationship between top management responsibility, policy, objectives, planning, implementation, measurement, review, and continual improvement.
  • The fundamental concepts and commonly used quality management terms and definitions

Fluency in written and spoken English

  • For participants whose first language is not English, we recommend a minimum English language competency of IELTS 5.5 (or equivalent) for successful completion of the program. This is not assessed by Comply Guru in advance & each participant must self-assess their competency.

Copy of ISO 13485 (International Standard)

  • It is recommended that each Learner should have a copy of ISO 13485:2016 (International Standard) to reference while completing this course. This is not provided by Comply Guru and without it, this course will be challenging to complete successfully.
How Will You Be Assessed

In order to successfully complete this course, each Learner will need to:

  • Complete the course modules and obtain 70% or higher in the final assessment (MCQ-based) within the 90-day course license
What Are The Technology Requirements

There are recommended requirements for each Learner in wishing to complete any of our eLearning modules. In our experience, Workplace IT environments’ internal configurations and available software can vary (new or old), and there may be various limitations or other restrictions in place, and as such, the functionality of any Learning Management System (LMS) may be impacted, restricted and may not perform well. Read the full technology requirements here.

About Our ISO 13485 Foundation Training

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Frequently Asked Questions

Yes, we permit substitutions provided the license has not been activated and this is requested within 30-days of the purchase date. There is no fee for substitutions.
Yes, we offer discounts. The first discount will apply for an order of 5 licenses (Team of 5). If you need more licenses, complete the request quote form as the discount will be applied based on the exact number of licenses required.
This course duration provided is an estimate based on a standard formula for the time it will take an average Learner. The precise amount of time it takes to complete the course will vary depending on your prior experience & learning style.
The standard license is for 90 days (3 months). Access is available 24/7 for the full 90-days even if you complete the course, you can still go back in and view the course content, but you cannot retake the assessments.
Each Learner is provided with 3 attempts at each final assessment. We strongly encourage all Learners to review the course content again before each attempt (if unsuccessful on an attempt). If unsuccessful after a 3rd attempt, a new course license is required (fee applies).
The fastest and easiest way to pay would be to use your credit card. If you cannot do that, and you require a PO, please email our team at training@complyguru.com
There are recommended requirements for each Learner in wishing to complete any of our eLearning modules. In our experience, Workplace IT environments’ internal configurations and available software can vary (new or old), and there may be various limitations or other restrictions in place, and as such, the functionality of any Learning Management System (LMS) may be impacted, restricted and may not perform well. Read the full technology requirements here.
Once you have completed the final assessments, your certificate will be available within 1 business day via your Dashboard. To access your certificate, you must first submit a short course survey and then the certificate will be available for download/print.
CQI & IRCA Accredited Training Provider

CQI & IRCA Accredited Training Provider

Offering certified courses since 2019

Exemplar Global Recognized Training Provider

Exemplar Global Recognized Training Provider

Offering certified courses since 2020