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MDSAP Requirements for Practitioners and Auditors

MDSAP Requirements Training for Practitioners and Auditors that provides learners with the knowledge required to understand the IMDRF Medical Device Single Audit Program (MDSAP) and the MDSAP audit approach. This course has been specifically designed for those who are new to MDSAP.

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.

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

RAPS Cretified Course
MDSAP Requirements for Practitioners and Auditors
 
Course Snapshot
Approved By
The Regulatory Affairs Professionals Society (RAPS)
RAPS Credits
12
Duration
12hrs
Teaching Format
eLearning
Certification of Completion
Yes
Language (s)
English
Learner Rating
★★★★★ 77 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
35mins eLearning

Module 1 – Introduction to MDSAP

  • History and Purpose of MDSAP
  • Structure and Scope of MDSAP
125mins eLearning

Module 2 – MDSAP Audits

  • Structure, Scope, and Sequence
  • Audit Cycle, Special and Unannounced Audits
  • Audit Time and Duration
  • Non-Conformity Grading
  • Reporting

Case Study! Role of the Australian Sponsor

Case Study! Audit Time Determination
95mins eLearning

Module 3 – MDSAP Chapters 1 and 2

  • Chapter 1 Introduction
  • Management Process Structure
  • What Auditors Look For (Chapter 1)
  • Jurisdictional Requirements
  • Chapter 2 Introduction
  • Process Structure
  • Country-specific Requirements
  • What Auditors Look For (Chapter 2)

Case Study! Jurisdictional Requirements

Case Study! Country-specific Requirements
110mins eLearning

Module 4 – MDSAP Chapters 3 and 4

  • Chapter 3 Introduction
  • Basis of Measurement, Analysis, Improvement (MAI)
  • Non-conforming Product Control
  • MAI and Internal Audits
  • What Auditors Look For (Chapter 3)
  • Chapter 4 Introduction
  • Overview of Task 1
  • Overview of Task 2

Case Study! Data Sources, Preventative Action, Verification of Effectiveness and Management Representative

Case Study! Process Change and Regulatory Impact

Case Study! Adverse Event Reporting
95mins eLearning

Module 5 – Design and Development

  • Introduction to Design and Development (D&D)
  • Audit Approach
  • Planning
  • Process
  • Design Transfer
  • Risk Management
  • Software
  • Change Management

Case Study! Outsourced Design and Development

Case Study! Software and Hardware Change
125mins eLearning

Module 6 – Production and Service Controls 

  • Introduction to Task 6
  • Tasks and Linkages 1 to 10
  • Tasks and Linkages 11 to 20
  • Tasks and Linkages 21 to 29

Case Study! Training and Documentation

Case Study! Medical Device File

Case Study! Control of Cleanliness of Product

Case Study! Software Validation
95mins eLearning

Module 7 – MDSAP Chapter 7 and Annexes 

  • Introduction to Chapter 7
  • Purchasing Tasks Overview
  • Purchasing Tasks 1 to 4
  • Purchasing Tasks 5 to 9
  • Purchasing Tasks 10 to 12
  • Additional Jurisdictional Requirements
  • The Annexes

Case Study! Technical Documentation

Case Study! Customer vs Supplier vs Outsourcing
40mins

Certification Exam

  • 30 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

MDSAP Requirements Training

Learning Objectives Covered

Explain the purpose and benefits of an MDSAP audit of a medical device quality management system

Identify the countries that recognize MDSAP audits

Explain the role of IMDRF and its members in the development of the MDSAP scheme

Explain the relationship between MDSAP, ISO 13485, and the regulatory requirements of the MDSAP member countries

Describe the MDSAP audit approach and the process for assessing conformity as described in MDSAP AU P0002

Who Should Attend

This course would be targeted at:

  • Quality assurance professionals
  • Quality Engineers
  • Research and Design Engineers
  • Internal Auditors
  • Quality Managers
  • Manufacturing Engineers
  • 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).

Successful completion will entitle each Learner to receive a digital Certificate of Completion.

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 and obtain 70% or higher in the final 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

About Our MDSAP Requirements Training

Learn about how our eLearning is leading the industry for innovation

 
Why Choose eLearning

Customer Reviews

What Our Learners Are Saying

Read verified reviews from Learners who have completed this course.

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.

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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