Date: 4 & & 10 & 16 December 2025 | Time: 3 PM – 5 PM NZT | Price: NZD 800 | Place: Online via Zoom
Prepare for the transition to the new Quality Management System Regulation (QMSR) with this focused six-hour training over three days. The US FDA’s adoption of ISO 13485:2016 brings key changes to 21 CFR Part 820, and this session will help you understand what’s changing and how to ensure compliance.
What You’ll Learn:
- Legal Framework for Medical Devices and QMS – The regulatory foundation for medical device quality management.
- Transition to QMSR – Key differences between 21 CFR Part 820 and the new requirements.
- Incorporation of ISO 13485:2016 – How the new QMSR aligns with the international standard.
- Steps to Implementation – Practical guidance on updating and maintaining a compliant QMS.
What You’ll Get:
- Presentation Slides – The key content will be provided in slide format for reference. Additional materials are not planned.
- Practical Guidance – Information on where to find further resources, including FDA publications and Medical Device University content.
- Interactive Q&A – Get expert answers to your specific challenges.
- Certificate of Completion – Proof of professional development.
Who Should Attend?
This training is ideal for quality and regulatory professionals preparing for the transition to QMSR. Gain practical insights and expert guidance to stay ahead of the regulatory changes and ensure your QMS remains compliant.
Meet Your Trainer
Margret Seidenfaden, MBA – Expert in Global Medical Device Compliance
With years of hands-on experience in regulatory affairs and quality management, Margret Seidenfaden has guided medical device manufacturers through the complex maze of international compliance. Having worked across global markets—including the USA, Canada, Europe, Brazil, China, and Australia—she knows exactly what it takes to successfully implement regulatory strategies and navigate evolving requirements.
Margret’s expertise lies in FDA regulations, ISO 13485, and the transition to QMSR, making her the perfect guide for this critical industry shift. She has trained and advised companies of all sizes, from startups to multinational corporations, ensuring they stay ahead of regulatory changes.
Expect practical insights, clear explanations, and real-world examples from someone who has been in the trenches of medical device approvals and compliance. If you want to understand QMSR, avoid compliance pitfalls, and get actionable steps to upgrade your QMS, this training is for you.
