MDSAP Auditor Skills Training that provides learners with the knowledge and skills required to understand and complete an audit against the IMDRF Medical Device Single Audit Program (MDSAP) for medical device quality management based on ISO 13485 and international regulatory bodies medical device regulations.

Our Blended Learning Methodology is a hybrid of 8hrs of highly interactive eLearning theory modules that are completed first before attending a 1-day skills-based Live Instructor Workshops that focuses on practical application in a real life context.

Why Choose Comply Guru?
 
Comply Guru
Globally Recognized Qualification
Industry-Leading Blended Methodology
Learn from Anywhere
Live Workshops led by Experienced Lead Auditors
More Flexibility & Less Downtime at Work
Better Prepared In Advance of Live Workshops
Course Snapshot
Accreditation
CQI & IRCA (No. 2694)
Duration
16hrs
Available Format
Blended Learning
Price
EUR €  895.00
Learner Rating
★★★★★ 18 Reviews
Upcoming Dates
7th May 2024 9:00 AM - 5:00 PM IST
11th Jul 2024 9:00 AM - 5:00 PM IST
20th Aug 2024 9:00 AM - 5:00 PM IST
Why Choose Comply Guru?
 
Comply Guru
Globally Recognized Qualification
Industry-Leading Blended Methodology
Learn from Anywhere
Live Workshops led by Experienced Lead Auditors
More Flexibility & Less Downtime at Work
Better Prepared In Advance of Live Workshops

Our Methodology

How Blended Learning Works

Blended learning is a two-step approach: Beginning with eLearning modules to grasp the foundational theory, then attending live, instructor-led classes emphasizing practical, real-world application.

How Blended Learning Works
How Blended Learning Works

Upcoming Schedule

Gain an Internationally Accredited Auditor Qualification

Advance your knowledge and enjoy more flexibility & learning effectiveness with blended learning.

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Workshop Dates
Daily Schedule
Course Delivery
Location
Fee
Registration
7th May 2024
9:00 AM - 5:00 PM IST
8hrs eLearning + 1-day Live Class
Virtual Workshops
EUR € 895.00
11th Jul 2024
9:00 AM - 5:00 PM IST
8hrs eLearning + 1-day Live Class
Virtual Workshops
EUR € 895.00
20th Aug 2024
9:00 AM - 5:00 PM IST
8hrs eLearning + 1-day Live Class
Virtual Workshops
EUR € 895.00

Course Overview

MDSAP Auditor Skills Training

Learning Objectives Covered

Explain the purpose of a medical device single audit program (MDSAP) medical device quality management system audit process in the context of ISO 13485 and regulatory compliance.

Explain the role and responsibilities of an auditor to plan, conduct, and report nonconformities for a quality management system audit in accordance with ISO 17021, regulatory body requirements and the MDSAP audit criteria.

Plan for and conduct an audit of a medical device quality management system, report, and grade non-conformities to establish compliance with ISO 13485 and regulatory requirements using MDSAP methodology.

What This Course Covers

A summary of learning topics within this course include:

  • Purpose and Benefits of an MDSAP Audit
  • Who Recognizes MDSAP Audits
  • Role of the IMDRF and its members, plus links between IMDRF and the GHTF
  • MDSAP’s Relationship to ISO 13485 and international regulatory requirement documents
  • MDSAP Competence and Training Requirements for Auditing Organizations
  • MDSAP potential application scope in relation to medical devices
  • MDSAP Audit Cycle
  • Planning Considerations for MDSAP Audits
  • 7 Chapters of MDSAP Audit Process
  • Non-Conformance Reporting as required by GHTF SG3 including escalation rules
  • Determining Audit Objectives
  • Audit Team Competencies & Selection
  • Conducting on-site audit activities including logistical planning, audit meetings, gather and verifying objective evidence and determining audit findings
  • Auditing using the MDSAP Approach
  • Generating Audit Findings
  • Reporting Audit Findings including grading requirements
Who Should Attend
  • Quality Assurance Professionals
  • Quality Engineers
  • Regulatory Professionals
  • Internal Auditors
  • Lead Auditors
Course Accreditation & Certificate

CQI IRCA

CQI & IRCA certify this course (No. 2694). Upon successful completion, each Learner shall receive a digital Certificate of Achievement.

What Are The Entry Requirements

Prior to attending this course, learners are expected to have the following prior knowledge:

ISO 13485

  • Knowledge of the ISO 13485 Requirements
  • Must have successfully completed a CQI and IRCA Certified MD-QMS ISO 13485 Internal or Lead Auditor course or equivalent.

Medical device management systems

Knowledge of the following quality management principles and concepts:

  • The relationship between ISO 13485 and applicable international regulatory requirements for medical devices.
  • Commonly used quality management terms and definitions within ISO 13485 and ISO 9000.
  • The process approach used in quality management.
  • A working knowledge of risk-management principles related to the design of a medical device, through ISO 14971.
How Will You Be Assessed

To successfully complete this course, each Learner will need to:

  • Complete the eLearning modules and obtain 70% or higher in the final assessments (MCQ-based) by the required deadline set in advance of the given workshop dates you are registered for.
  • Fully attend the Instructor Workshops as 100% attendance is required.
  • Obtain 70% or higher in the graded assessments during the Instructor Workshops
What Are The Technology Requirements

For the live workshops during a virtual delivery, we utilise both Zoom and Microsoft Teams.

Learners need to individually have:

  • PC or MAC Computer
  • Reliable Internet
  • Video Webcam
  • Headset or Earbuds
  • Quiet Setting

In relation to the 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.

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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.
Yes, we offer in-house training and if you have 5 or more learners that can be trained together, we strongly recommend arranging for in-house training. With this option, there is the possibility of customizing some elements of the training to your organization. Please request a quote and a member of our team will be in touch to discuss this further with you.
A blended learning course is a hybrid of eLearning modules and classroom modules (in-person or virtual). Each Learner is required to successfully complete interactive eLearning modules in advance of the live workshops that form the second phase of the training.
We keep our classes to 10 or 12 maximum depending on the blended course, to ensure you can enjoy breakout rooms, activities and Q&As with the Instructor and other participants.
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.
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.
Once you have completed the full program, including examination (if applicable), your certificate will be available within 30 business days via your Dashboard once all examination grading has been completed & verified. 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