Online & Self-Paced Medical Device Single Audit Program (MDSAP) Foundation Course


  • Course Area:

    Medical Devices

  • Course Duration:

    8 Hours

  • Format:

    Online & Self-Paced Course

  • Accreditation:

    CQI and IRCA approved training partner
  • Individual Pricing:

    495 per person

  • Team Pricing:

    Need more! Call us

Finally, an industry-leading online, blended & virtual training solution for ISO Standards, Quality Auditing & Medical Device Regulations!

Comply Guru offers a growing portfolio of online, virtual & blended training courses on various ISO Standards, Quality Auditing & Medical Device Regulations to enable its Learners to get the knowledge and skills they need from home, work or anywhere!

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Our Exemplar Global Certified Online & Self-Paced Course aims to provide learners with the knowledge required to understand the IMDRF Medical Device Single Audit Program (MDSAP) for medical device quality management based on ISO 13485:2016 and international regulatory bodies medical device regulations.

Learning Objectives:

  1. Explain the purpose and benefits of a MDSAP audit of a medical device quality management system
  2. Identify the countries that recognise 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 13485:2016 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

Course Certification

This course will be offered with Exemplar Global Certification. Successful completion will entitle each Learner to receive a digital Exemplar Global Recognized Certificate of Completion.

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

Assessment Methodology

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

  • Complete the online course modules and obtain 70% or higher in the final assessment (MCQ-based)

Course Access & Support

Upon registering for this course, a Learner will be able to avail of the following:

  • Course Access for 90-days
  • Phone & Email Support (Virtual Instructor)
  • Module 1: Introduction to MDSAP

    • What is MDSAP?
    • Purpose and benefits of MDSAP
    • Role of IMDRF in development of MDSAP
    • MDSAP Members, Official Observers and Affiliate Members
    • Relationship with ISO 13485:2016 and regulatory requirements
    • MDSAP Guidance Documents

  • Module 2: MDSAP Audit

    • MDSAP Structure
    • Audit Sequence
    • MDSAP Audit Cycle
    • Special and Unannounced Audits
    • Audit Time and Duration
    • Introduction to MDSAP NC Grading
    • How the MDSAP Certificate / Reports are used by Regulators

  • Module 3: MDSAP Requirements - Chapter 1 and 2

    • Introduction to Chapter 1 and 2
    • Chapter 1 Management Tasks 1-11
    • Additional Country Specific Requirements
    • Chapter 2 Tasks 1-3
    • Additional Country Specific Requirements

  • Module 4: MDSAP Requirements - Chapter 3 and 4

    • Introduction to Chapter 3 and 4
    • Chapter 3 Tasks 1-16
    • Additional Country Specific Requirements
    • Chapter 4 Tasks 1-2
    • Additional Country Specific Requirements

  • Module 5: MDSAP Requirements - Chapter 5

    • Introduction to Chapter 5
    • Project selection and planning
    • Design and development inputs
    • Verification, validation, clinical evaluation
    • Design change, review and transfer
    • Software design and development

  • Module 6: MDSAP Requirements - Chapter 6

    • 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

  • Module 7: MDSAP Requirements - Chapter 7 and Annexes

    • 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

    E-Learning System Requirements

    The below are the recommended requirements for each Learner in wishing to complete any of our online training courses or 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.

    Recommended Operating Systems

    Windows 7/10, Mac OSX Sierra, iPad IOS10

    Mobile Devices

    Comply Guru’s LMS is not available on a mobile app at this time. We recommend using a web browser on a mobile device in completing any online modules. However, if completing any final graded assessment, we recommend completing via a desktop browser.

    Internet Speed

    We recommend using an internet connection of 256Kbit/sec or faster that will ensure that you can view videos and the online content

    Recommended Internet Browsers

    • Google Chrome 32 bit version 50 or later
    • Safari 10 or later
    Important Note: add-ons and toolbars can affect any browsers performance. MS Internet Explorer or Edge is not recommended as its not compatible with the LMS and the course functionality will not work properly.

    Recommended Settings

    We recommend that the following settings are enabled:
    • Cookies
    • Pop-ups (in both Internet Browser and security software)
    • JavaScript
    • Plugins
    • Latest Version of Adobe Flash Player
    • Latest Version of Adobe Acrobat Reader
    To view all resources made available within our LMS, you will probably need Microsoft Office (Word, Excel, PowerPoint) or an equivalent (i.e Open Office, Viewer) installed.

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