MDSAP - Background and Fundamentals for improved Market Access Understanding the Global Audit Framework for Regulatory Efficiency and Compliance

Expanding into international markets requires more than just compliance, it demands a clear understanding of global regulatory frameworks. Since its inception, the Medical Device Single Audit Program (MDSAP) has established itself as a gold industry standard for the auditing and certification of medical device legal manufacturers and is widely recognized not only by the MDSAP Regulatory Authorities in Australia, Brazil, Canada, Japan and USA but also by a range of other international regulatory bodies.

MDSAP represents a transformative initiative in medical device regulation, designed to reduce redundancy in regulatory audits and streamline market access across multiple jurisdictions. For manufacturers aiming to place products in several international markets, MDSAP offers a single, comprehensive audit based on ISO 13485:2016 and supplemented with relevant country specific regulatory requirements that satisfies the requirements of up to 5 jurisdictions.

This training delivers a deep dive into the structure and operational fundamentals of MDSAP, enabling organizations to adopt a global mindset in regulatory compliance. It is particularly valuable for manufacturers navigating complex quality and regulatory landscapes, especially those expanding into Canada, the U.S., Brazil, Japan, and Australia, the five current MDSAP participating countries.

More than just a certification pathway, MDSAP provides a strategic framework for aligning quality systems with international best practices, reducing audit fatigue, and maintaining robust compliance standards. Understanding and integrating MDSAP can lead to faster regulatory approvals, fewer inspections, and improved global credibility.

Content Overview

• Understand the purpose, structure, and regulatory landscape of MDSAP
• Identify audit cycles, grading non-conformities, and key audit processes
• Explore how MDSAP supports faster and broader market access
• Gain insights into common challenges and practical preparation strategies such as aligning internal QMS procedures with MDSAP expectations
• Tools for assessing readiness, managing audit nonconformities, and integrating MDSAP into broader compliance strategies
• Inputs about the  MDSAP Audit Approach revision 11 

Target Audience

Regulatory Affairs, Quality Assurance & QMS Management, RA/QA, Executive Management who want to strengthen their organization’s global compliance pathway.

Benefit

For companies looking to maintain or expand their global market presence, MDSAP is not just an option, it’s becoming a competitive necessity and can help your organization demonstrate a higher level of QMS maturity, reduce audit overlap, and create opportunities for internal process optimization.

Certificate

Participants receive a Certificate of Attendance of DQS MED GmbH

Agenda

Please note that the agenda is a general outline and individual modules may vary in duration.

09:00 - 09:15 - Welcome and Introduction

·         Trainer introduction

·         Participant expectations

·         Training objectives and agenda overview

·         Current global regulatory challenges for medical device manufacturers

09:15 - 10:00 - Module 1: MDSAP Overview and Regulatory Landscape

·         Understand the purpose and history of MDSAP

·         Recognize participating Regulatory Authorities and stakeholders

·         Understand the relationship between ISO 13485 and MDSAP

10:00 - 10:45 - Module 2: MDSAP Audit Model and Audit Process

·         The seven MDSAP processes

·         Initial certification, surveillance, and recertification audits

·         Audit duration determination

·         Audit trail methodology

·         Roles and responsibilities during audits

10:45 - 11:00 - Coffee Break

11:00 - 12:00 - Module 3: MDSAP Audit Approach Revision 11

·         Overview of Revision 11

·         Process interaction and audit sequence

·         New or revised task requirements

·         Country-specific regulatory considerations

·         Expected audit focus areas

12:00 - 12:30 - Module 4: Nonconformity Grading and Regulatory Consequences

·         MDSAP grading methodology

·         Determining severity levels

·         Escalation scenarios

·         Examples of common findings

·         Regulatory reporting expectations

12:30 - 13:00 - Lunch Break

13:00 - 14:00 - Module 5: Practical Preparation for an MDSAP Audit

·         Internal readiness assessments

·         Aligning QMS processes with MDSAP requirements

·         Management responsibility and process ownership

·         CAPA effectiveness

·         Risk management integration

·         Supplier controls and purchasing processes

14:00 - 14:45 - Module 6: Strategic Value of MDSAP and Market Access

·         Market access benefits

·         Inspection reduction opportunities

·         Leveraging MDSAP for organizational improvement

·         Integration with MDR, FDA QMSR, and other regulatory frameworks

·         Typical challenges and success factors

14:45 - 15:00 - Final Q&A and Wrap-Up

·         Key takeaways

·         Participant questions

·         Resources and further learning

·         Certificate information

·         Closing remarks