Medical Device Single Audit Program (MDSAP) Auditor Training



The aim of this course is to provide learners with an appreciation or the knowledge and skills required to complete an audit against the IMDRF Medical Device Single Audit Program (MDSAP AU P0002.004) for medical device quality management based on ISO 13485:2016 and international regulatory bodies medical device regulations. Audit principles in accordance with ISO 17021.

More information coming soon!

Course Snapshot

  • Course Duration:

    16 Hours
  • Format

    Blended Course (6hrs Online & Self-Paced + 1-day Virtual Classroom)
  • Accreditation

    CQI and IRCA approved training partner
    Comply Guru Certified Course
  • Delivery Options & Discounts

    • Available as a blended course including virtual classroom
    • Available on select public dates & for in-house training for groups of 5+!
    • Multi-Person Discount: Book 3, get a 4th Place Free (Same Course & Dates Apply)
  • Price

    Not Yet Available
  • Fee Includes

    • Comprehensive Course Manual
    • Virtual Instructor Assistance – Phone & Email Support (Online Modules)
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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!

Start DateLocationCostDurationOnsite/Virtual Classroom


6 Hours (Online & Self-Paced) + 1 Days (Virtual Classroom)
Prior to attending this course learners should have the following prior knowledge. ISO 13485
  • Knowledge of the requirements of ISO 13485, which may be gained by completing a CQI and IRCA Certified ISO 13485:2016 Foundation training 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
  • Understand risk management principles related to the design of a medical device quality management systems (e.g. through ISO 14971).
Important Note: Learners who have not satisfactorily completed a CQI and IRCA Certified Lead Auditor training course (or acceptable alternative) may not successfully complete this course.

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The Numbers - How We Are Doing

  • 100%

    Our Pass Rate

  • 100%

    Would Recommend Comply Guru

  • 97%

    Gave us 4/5 Stars or higher Overall Training Experience

  • 96%

    Would Recommend Online or Blended Training over Classroom Training

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