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FDA QMSR and ISO 13485 Requirements for Practitioners and Auditors

FDA QMSR Requirements Training (incl. ISO 13485) is for Practitioners and Auditors who wants to understand the requirements, including similarities, differences and key aspects of both the ISO 13485 standard and the FDA Quality Management System Regulation (Revised Part 820).

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

The Regulatory Affairs Professionals Society (RAPS) recognize this course offering global recognition for successful participants and RAPS credits for members.

RAPS Cretified Course
FDA QMSR and ISO 13485 Requirements for Practitioners and Auditors
 
Course Snapshot
Approved By
Regulatory Affairs Professionals Society (RAPS)
RAPS Credits
12
Duration
16hrs
Teaching Format
eLearning
Certification of Completion
Yes
Language (s)
English
Price Limited Time
£895.00 £795.00
Learner Rating
★★★★★ 3 Reviews

Have 5 or more that need training?

We offer group discounts and are available for in-house (live or virtual) or tailored training in multiple formats.

Our Methodology

Not all eLearning is the same

Most other providers offer online training that is one-dimensional utilizing either Videos or PowerPoint Presentations. That is not effective training. We deploy a multi-layered methodology that offers you a New Generation of eLearning.

Not all eLearning is the same
Not all eLearning is the same
 

Course Structure Explained

eLearning Module Breakdown & Timings

An interactive, engaging eLearning experience that you can complete Anytime, Anywhere.

Time Topic
60mins eLearning

Module 1 – Introduction to the new FDA QMSR

  • History of the QMSR
  • QMSR Structure
  • QMSR Scope
  • Definitions
  • QMSR and ‘Risk’
105mins eLearning

Module 2 – Overview of ISO 13485

  • Introduction to ISO 13485
  • Terms and Definitions
  • Plan-Do-Check-Act
  • Documentation Requirements
  • Process Based QMS
  • Risk Based Thinking (RBT)
  • Management Commitment
  • Related Standards

Case Study! Terms and Definitions

Case Study! KPIs

Case Study! Risk Management and Supplier Qualification
120mins eLearning

Module 3 – Establishing a Quality Management System

  • Establishing a Quality Management System (QMS)
  • QMS Documentation
  • Assessing for Conformity

Case Study! Software Validation

Case Study! Complaint Handling Records
90mins eLearning

Module 4 – Management Responsibility

  • Management Commitment
    & Customer Focus
  • Quality Policy, Objectives & Planning
  • Responsibility, Authority
    & Communication
  • Management Review
  • Assessing for Conformity

Case Study! Quality Objectives

Case Study! Management Review
75mins eLearning

Module 5 – Resource Management

  • Provision of Resources
  • Infrastructure & Work Environment
  • Assessing for Conformity

Case Study! Infrastructure and Equipment Maintenance
135mins eLearning

Module 6 – Product Realization, Part 1

  • Planning
  • Customer Related Processes
  • Design & Development
  • FDA Device Classification & Regulatory Controls
  • Assessing for Conformity

Case Study! Risk Management

Case Study! Customer Related Processes

Case Study! Design Planning
105mins eLearning

Module 7 – Product Realization, Part 2

  • Purchasing
  • Production & Service
  • Control of Monitoring & Measuring
  • Assessing for Conformity

Case Study! Purchasing

Case Study! Calibration Requirements
90mins eLearning

Module 8 – Measurement, Analysis, and Improvement

  • MAI Overview
  • Monitoring & Measuring
  • Control of Nonconforming Product
  • Data Analysis and CAPA
  • Assessing for Conformity

Case Study! Feedback

Case Study! Audit Records

Case Study! Audit Management

Case Study! Incoming Inspection
60mins

Certification Exam

  • 40 MCQ-based eAssessment with 70% or higher required to achieve certification

Our Experts

Meet The People Behind The Course

Our experts possess a wealth of industry experience acquired over years of practical application, and in addition, they demonstrate a combination of unwavering passion and a proven aptitude for training.

Michelle Keane

Our Instructor

Michelle Keane

Michelle has a proven track record with over 20 years of experience working across both the Medical Device and Biotechnology sectors. Currently, she is a Lead Auditor for an INAB Accredited Certification Body, and an MDR Assessor for a Notified Body in Europe. In addition, she is the Team PRRC Representative for Ireland.
Leon Donnellan

Our Graphical & Instructional Designer

Leon Donnellan

Leon has over 20 years of experience in eLearning. During his illustrious career, he has spent 10+ years designing programs within highly regulated industries. He brings vast experience to Comply Guru in both graphical and instructional design.
Eoin Philip Kelly

Our Training Specialist

Eoin Philip Kelly

Eoin has almost 20yrs of experience in internationally accredited training design & delivery. He founded Comply Guru to pursue his vision to bridge the major gap in the market for learning solutions that were more accessible, convenient & flexible in a fast-changing world of International Standards & Medical Device Regulations.

Course Overview

FDA QMSR + ISO 13485 Practitioner Training

Learning Objectives Covered

Understand how the FDA QMSR has evolved to align with ISO 13485 more closely

Outline the structure, content & requirements of both the FDA QMSR and ISO 13485

Understand the key similarities and differences between the FDA QMSR and ISO 13485

Detail the specific quality management-related requirements of the FDA QMSR and ISO 13485

Understand how auditors approach Quality Management System Audits to ensure compliance with the FDA QMSR and ISO 13485

Who Should Attend

This course would be targeted at:

  • Quality Engineers
  • Quality Specialists
  • Internal Auditors
  • Lead Auditors
  • Quality Managers
  • Regulatory Professionals
Course Certification

RAPS Approved Provider Logo

The Regulatory Affairs Professionals Society has approved Comply Guru (No. 1007) and recognizes this course where members will be eligible for the stated number of RAPS credits (12).

Upon successful completion, each Learner shall receive a digital Certificate of Achievement 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
How Will You Be Assessed

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

  • Complete the eLearning modules & associated end-of-module assessments
  • Obtain 70% or higher in the final end-of-course assessment (MCQ-based)
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.

Why Choose Comply Guru

Who Choose Our eLearning?

Learn about how our eLearning methodology is leading the industry for innovation through online learning

 
Why Choose eLearning

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What Our Learners Are Saying

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Globally Recognized Qualifications
Training credentials that you can trust.
CQI & IRCA Approved Training Provider
Exemplar Global Recognized Training Provider
RAPS Recertification Approved Provider