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8hrs Online Course USD $ 695.00 ★★★★★ 25 Reviews

MDSAP Auditor Foundation Training that provides learners with the knowledge required to understand the IMDRF Medical Device Single Audit Program (MDSAP) and the MDSAP audit approach.

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MDSAP Requirements & Auditor Foundation Training

Key Course Information

What you need to know?

Our industry-leading 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.

Available Formats:

eLearning

eLearning

Customized Learning

Customized Learning

Learning Objectives Module Content Who Should Attend? Entry Requirements Assessment Methodology Course Accreditation Technology Requirements

Learning Objectives

On completion of this course, successful Learners will have the knowledge needed to:

  1. Explain the purpose and benefits of an MDSAP audit of a medical device quality management system
  2. Identify the countries that recognize MDSAP audits
  3. Explain the role of IMDRF and its members in the development of the MDSAP scheme
  4. Explain the relationship between MDSAP, ISO 13485, and the regulatory requirements of the MDSAP member countries
  5. Describe the MDSAP audit approach and the process for assessing conformity as described in MDSAP AU P0002.006

Module Content

A summary of learning topics within this course include:

  • What is MDSAP?
  • Purpose and benefits of MDSAP
  • Role of IMDRF in the development of MDSAP
  • MDSAP Members, Official Observers, and Affiliate Members
  • Relationship with ISO 13485 2016 and regulatory requirements
  • MDSAP Guidance Documents
  • MDSAP Structure
  • Audit Sequence
  • MDSAP Audit Cycle
  • Special and Unannounced Audits
  • Audit Time and Duration
  • Introduction to MDSAP NC Grading
  • Introduction to Chapters 1 and 2
  • Chapter 1 Management Tasks 1-11
  • Additional Country-Specific Requirements
  • Chapter 2 Tasks 1-3
  • Additional Country-Specific Requirements
  • Introduction to Chapters 3 and 4
  • Chapter 3 Tasks 1-16
  • Additional Country-Specific Requirements
  • Chapter 4 Tasks 1-2
  • Additional Country-Specific Requirements
  • Introduction to Chapter 5
  • Project selection and planning
  • Design and development inputs
  • Verification, validation, and clinical evaluation
  • Design change, review, and transfer
  • Software design and development
  • Introduction to Chapter 6
  • Tasks 1-9 including country-specific requirements
  • Tasks 10-19 including country-specific requirements
  • Tasks 20-29 including country-specific requirements
  • Introduction to Chapter 7
  • Tasks 1-6 including country-specific requirements
  • Tasks 7-12 including country-specific requirements
  • Annex 1 and Annex 2
  • Annex 3 Adverse Events and Advisory Notices Reporting
  • Annex 4 Written Agreements

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

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

Assessment Methodology

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) within the 90-day course license

Course Accreditation

Exemplar Global

Exemplar Global certifies our MDSAP Requirements & Auditor Foundation Training. Successful completion will entitle each Learner to receive a digital Certificate of Completion.

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.

Pricing

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Secure Payment

Individual
USD $ 695.00
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Team of 5
USD $ 3300.00
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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