Medical Device Single Audit Program (MDSAP): Requirements and Preparation

This course is recommended for:

• Medical device manufacturers
• Quality Management System professionals
• Regulatory Affairs professionals
• Quality Assurance professionals
• Compliance managers
• Internal auditors
• Supplier quality professionals
• Professionals preparing for MDSAP implementation or audits
• Personnel responsible for ISO 13485 compliance and regulatory submissions

1. Introduction to MDSAP

• Background and objectives of MDSAP
• IMDRF and participating regulatory authorities
• MDSAP benefits and global market access opportunities
• Roles of Auditing Organizations

2. MDSAP Regulatory Requirements

• Participating jurisdictions
• Country-specific regulatory requirements
• Regulatory expectations and market access implications

3. MDSAP Audit Model

• Audit approach structure
• Process-based audit methodology
• Audit sequence and linkages
• Audit lifecycle and certification cycle

4. MDSAP Audit Activities

• Stage 1 and Stage 2 audits
• Surveillance audits
• Recertification audits
• Special and unannounced audits

5. MDSAP Processes

• Management
• Device Marketing Authorization and Facility Registration
• Measurement, Analysis and Improvement
• Medical Device Adverse Events and Advisory Notices Reporting
• Design and Development
• Production and Service Controls
• Purchasing

6. Technical Documentation Requirements

• Medical Device Files
• Design and Development Files
• Technical documentation expectations
• Product and process-related technologies

7. Nonconformity Grading

• MDSAP grading methodology
• Repeat nonconformities
• Escalation criteria
• Response timelines

8. Audit Time Calculation

• Audit task determination
• Time calculation methodology
• Audit duration considerations

9. Preparing for an MDSAP Audit

• Readiness considerations
• Common challenges
• Documentation preparation
• Audit preparation best practices

10. Practical Exercises and Discussion

• Case studies
• Audit scenarios
• Interactive exercises

The Medical Device Single Audit Program (MDSAP) was developed by the International Medical Device Regulators Forum (IMDRF) to enable a single regulatory audit of a medical device manufacturer’s quality management system. The program promotes greater regulatory harmonization and allows participating authorities to leverage a common audit approach while reducing duplicate regulatory audits.

This course provides a comprehensive overview of the MDSAP framework, its objectives, participating regulatory authorities, and the benefits that MDSAP participation can bring to medical device manufacturers operating in international markets. Participants will learn how MDSAP supports regulatory compliance and facilitates market access across key jurisdictions including Australia, Brazil, Canada, Japan, and the United States.

The training explains the MDSAP audit model in detail, including the audit sequence, audit lifecycle, audit processes, nonconformity grading methodology, audit time determination, and country-specific regulatory requirements. Participants will gain insight into how MDSAP audits are planned, conducted, and evaluated by recognized Auditing Organizations.

Through practical examples and exercises, learners will explore the structure of the MDSAP Audit Approach, understand how audit findings are graded, and identify the documentation, records, and quality management system controls necessary for successful audit outcomes.

Upon completion, participants will be able to interpret MDSAP requirements, understand auditor expectations, identify potential areas of regulatory risk, and establish effective strategies for preparing their organizations for MDSAP audits and ongoing compliance activities.

With this training, you will be able to:

• Understand the structure and objectives of the Medical Device Single Audit Program (MDSAP)
• Gain insight into the MDSAP Audit Approach and audit sequence
• Understand the regulatory expectations of participating MDSAP jurisdictions
• Learn how audit findings are evaluated and graded under the MDSAP model
• Identify documentation and quality system requirements needed for audit readiness
• Improve preparation for initial, surveillance, and recertification MDSAP audits
• Support more efficient global market access through a harmonized audit framework

This instructor-led training is delivered in a live virtual classroom environment. The course combines:

• Expert-led presentations
• Interactive discussions
• Practical examples
• Case studies
• Group exercises
• Knowledge-sharing activities
• Q&A sessions

Participants have direct interaction with the instructor and fellow attendees throughout the training.

• Active participation in course discussions and practical exercises
• Knowledge checks, review questions, and instructor-led discussions throughout the course

• Participants who attend at least 90% of the total training duration will receive a Certificate of Attendance from TÜV SÜD Academy upon successful completion of the training.

Participants will receive:

• Participant workbook/training materials
• Presentation slides and supporting reference materials
• Practical exercises and case study materials
• Certificate of Attendance

No prior knowledge of MDSAP is required.

However, a basic understanding of:

• Medical device quality management systems
• ISO 13485
• Medical device regulatory requirements

is beneficial.

This training course is part of a modular learning path. After successful participation in the advanced modules, you can acquire this recognized qualification: Manager Regulatory Affairs international – TÜV

What is MDSAP?

MDSAP is the Medical Device Single Audit Program, a regulatory audit program that allows a single audit of a medical device manufacturer's quality management system to satisfy the requirements of multiple participating regulatory authorities.

Which countries participate in MDSAP?

The core participating regulatory authorities include Australia (TGA), Brazil (ANVISA), Canada (Health Canada), Japan (MHLW/PMDA), and the United States (FDA).

Is MDSAP certification mandatory?

MDSAP participation requirements depend on the jurisdiction and regulatory pathway. For example, Health Canada requires MDSAP certification for Class II, III, and IV medical device licensing.

Does this course teach how MDSAP audits are conducted?

Yes. The course explains the MDSAP Audit Approach, audit sequence, audit lifecycle, audit processes, and auditor expectations.

Will country-specific requirements be covered?

Yes. The training reviews regulatory requirements applicable to Australia, Brazil, Canada, Japan, and the United States as incorporated within MDSAP audits.

Does the course cover MDSAP nonconformity grading?

Yes. Participants learn the MDSAP grading methodology, escalation criteria, repeat nonconformities, and response expectations.

Will I learn how to prepare for an MDSAP audit?

Yes. Audit preparation is a key part of the course and includes documentation expectations, audit readiness considerations, and common audit challenges.

Is prior MDSAP experience required?

No. The course is designed both for professionals new to MDSAP and for those seeking a deeper understanding of MDSAP audit requirements.

Does the course include practical examples?

Yes. Participants work through practical examples, exercises, and audit scenarios to reinforce learning.

What certificate will I receive?

Participants who complete the training will receive a TÜV SÜD Certificate of Attendance.

 Experienced specialist trainers from the TÜV SÜD Academy with practical knowledge in medical devices.