Training Features

MDSAP Methodology

Transform complex global audit requirements into a clear and structured approach with MDSAP expertise with this e-learning.
Format

E-Learning

Level

Advanced

Trainer

Olena Hoi

Exam

Exam and certificate included

Duration

4 hours
10 modules

Price

€ 565 or equivalent currency

Build Confidence in the MDSAP Methodology

Develop a thorough, practical understanding of the Medical Device Single Audit Program (MDSAP) and its impact on global regulatory compliance. In this advanced e-learning, you will explore the full audit model, from structure and process flow to audit execution and nonconformity grading. 

Designed for professionals already familiar with ISO 13485, this training provides the insights and tools needed to navigate MDSAP audits with confidence, align your quality management system with international expectations, and reduce regulatory complexity across multiple markets.
What You Will Learn
Who Should Attend?
What is Included?
Course Details
By the end of this training, you will be able to:
  • Explain the fundamentals, objectives, and global context of the MDSAP program
  • Interpret the MDSAP audit model, including its process-based approach and audit sequence
  • Understand the roles and interactions of key stakeholders, including Regulatory Authorities and Auditing Organizations
  • Navigate the full MDSAP audit cycle, from initial certification through surveillance and recertification audits
  • Apply knowledge of nonconformity grading, audit outcomes, and regulatory implications to real-world scenarios.
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. 4 hours.
  • Format: Self-paced e-learning (video, interactive content, and quizzes).
This training is designed for:
  • Regulatory Affairs professionals working with global market access
  • Quality Assurance specialists involved in QMS implementation or maintenance
  • Professionals preparing for or supporting MDSAP audits
  • Consultants and auditors in the medical device industry
  • Anyone with prior knowledge of ISO 13485 seeking to deepen their understanding of MDSAP methodology.

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.