Mastering MDSAP: Your gateway to global market confidence
Discover how MDSAP simplifies compliance and accelerates access to key international markets
Expanding into global markets presents increasing regulatory complexity for medical device manufacturers. Overlapping country specific audits can lead to delays, duplicated efforts, and added strain on resources.
The Medical Device Single Audit Program (MDSAP) was developed to address this challenge. It allows manufacturers to meet the requirements of multiple regulatory authorities, including the US FDA, Health Canada, TGA (Australia), ANVISA (Brazil), and MHLW (Japan), through a single, harmonized audit. Beyond simplifying compliance, MDSAP helps build trust in your quality system, reduce audit fatigue, and accelerate market access.
Join us in this one-hour webinar, you’ll discover how MDSAP works, how it enables efficient multi market compliance, and what it takes to prepare confidently for certification, all supported by insights from DNV’s global medical device certification expertise.
Date: 8 August 2025
Time: 14:00 PM – 15:00 PM SGT (GMT+8)
Speaker: Nurfarahin Mohd Johan, Senior Auditor
Key takeaways:
- Why MDSAP is a competitive advantage in today’s global certification landscape
- Understanding the MDSAP framework and its alignment with ISO 13485
- Exploring the strategic value through the business case, cost benefits and quality impact of MDSAP
- Preparing for a successful MDSAP audit with gap assessment, documentation alignment and team readiness
- How DNV could partner with you for the MDSAP certification
This webinar will help you understand how MDSAP can be more than a compliance requirement, it can be a strategic tool for expanding into global markets. You will gain actionable insights to strengthen your internal systems, navigate complex regulatory expectations, and prepare effectively for certification, all guided by DNV’s trusted expertise.