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

Interested participants from other time zones are welcome to contact us regarding the training at [email protected].

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

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

Trainer: Is a highly qualified regulatory expert from DQS MED, a leading Notified Body with deep expertise in conformity assessment under EU MDR.