Training Features

Introduction to MDSAP Methodology: A Beginner’s Guide

Build your foundation in MDSAP methodology with this beginner‑focused course that demystifies the audit approach and prepares you for effective participation in global regulatory audits.
Format

E-Learning

Level

Beginner

Trainer

Olena Hoi

Exam

Exam and certificate included

Duration

2 hours
10 modules

Price

€ 345 or equivalent currency

Introduction to MDSAP Methodology

Get started with MDSAP in this beginner-level e-learning designed to give you a clear understanding of the Medical Device Single Audit Program and its audit approach. Learn why MDSAP matters, how audits are structured, and the key concepts you need to confidently engage with this global regulatory program.

This course is perfect if you’re new to MDSAP or preparing to support your organization’s first audit. Gain essential knowledge of the audit process, the role of auditing organizations, and how MDSAP fits into the broader medical device regulatory landscape.

For successful completion of this course, it is expected that attendees have prior knowledge of the ISO 13485:2016 standard.
What You Will Learn
Who Should Attend?
What is Included?
Course Details
By the end of this course, participants will be able to:
  • Explain the purpose and benefits of the Medical Device Single Audit Program (MDSAP) in the global medical device regulatory environment.
  • Describe the structure and stages of an MDSAP audit and the key roles involved.
  • Identify the responsibilities of a medical device organization in preparing for and supporting an MDSAP audit.
  • Recognize common audit criteria and processes used by auditing organizations.
  • Connect MDSAP requirements to broader regulatory expectations and compliance obligations.
What is included in this e-learning?
  • Access to the Qserve Learn Training Portal
  • A training certificate upon completion of the training.
Access to any mentioned guidances or ISO standards that are not publicly available is not included in this e-learning.
  • Duration: Approx. 2 hours
  • Format: Self-paced e-learning (video, interactive content, and quizzes).
This course is ideal for professionals who want to build a solid foundation in MDSAP and be well-prepared to support or participate in audits:
  • Professionals new to MDSAP seeking a foundational understanding of the program.
  • Quality, regulatory, or compliance team members supporting their organization’s first MDSAP audit.
  • Individuals involved in internal audit preparation or process alignment for medical devices.
  • Staff responsible for coordinating with auditing organizations or regulatory authorities.
  • Anyone interested in understanding global medical device audit practices and requirements.

Comprehensive Regulatory Expertise

Advance your career by mastering the standards that define global medical device compliance, all through a flexible learning schedule.
Upon successful completion of the program, participants receive a recognized certification, boosting their career prospects and demonstrating their expertise to employers and clients.

Certification and Career Advancement

We offer a flexible learning schedule, allowing professionals to balance their training with their busy work and personal lives, ensuring accessibility to a wide range of learners.

Flexible Learning Schedule

Modules

Explore the training modules available in this course

Meet the Trainer

Olena Hoi

Olena is a seasoned Quality and Regulatory Affairs Consultant at Qserve Group with extensive experience in managing Quality Management Systems, conducting audits, and authoring regulatory submissions for high-risk medical devices across global markets, particularly in the EU under MDR and MDD regulations.