ISO 13485:2016 – Introduction & Implementation with FDA QMSR (USA/Canada) — 2026 Update
The ISO 13485:2016 – Introduction & Implementation with FDA QMSR (USA/Canada) — 2026 Update by TÜV SÜD equips medical device quality managers and regulatory affairs specialists with the skills to align their QMS with ISO 13485:2016 and the FDA’s new QMSR effective February 2, 2026. With 90% of leading medical device firms adopting ISO 13485, this course addresses the urgent need to transition from legacy 21 CFR 820 to the harmonized QMSR framework, including the Medical Device File (MDF) and expanded FDA audit expectations.
This TÜV SÜD course prepares learners for Exemplar Global certification and includes official vendor-authorized courseware with 30-day lab access. Gain the expertise to lead compliance efforts in North America’s evolving regulatory landscape and ensure your organization meets FDA and Health Canada requirements with confidence.
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Course Overview
The ISO 13485:2016 – Introduction & Implementation with FDA QMSR (USA/Canada) — 2026 Update by TÜV SÜD is a comprehensive two-day virtual training designed for medical device professionals preparing for global regulatory compliance. This course equips participants with foundational and practical knowledge of ISO 13485:2016 and its integration with the upcoming U.S. FDA Quality Management System Regulation (QMSR), effective February 2, 2026. Targeted at Quality Management Officers, Regulatory Affairs Specialists, and Quality Engineers, the program addresses critical transitions such as the replacement of legacy DHF/DMR/DHR documentation with the Medical Device File (MDF). With over 90% of Class II–IV medical device manufacturers in North America required to comply with MDSAP and the new QMSR, this training meets urgent industry demand for aligned, up-to-date quality system expertise.
Participants engage with key regulatory and quality frameworks including ISO 13485:2016, FDA QMSR (21 CFR 820), Canadian CMDR/MDSAP requirements, and ISO 14971 risk management principles. The hands-on implementation workshop allows learners to map ISO 13485 clauses to real-world organizational processes, develop MDF structures, and conduct internal audit simulations within a live virtual classroom environment. Led by TÜV SÜD’s industry experts, the lab exercises focus on practical applications such as traceability from design to post-market surveillance, supplier control integration, and risk-based process validation. These activities are delivered through interactive case studies, group problem-solving, and real-time Q&A sessions, ensuring participants gain actionable skills for immediate deployment.
This course prepares professionals for global certification and audit readiness, reinforcing the international recognition of ISO 13485:2016 as the benchmark for medical device quality management systems. Graduates receive a TÜV SÜD Certificate of Attendance, a credential valued across the $600 billion medical technology sector where compliance roles command average salaries exceeding $95,000 in the U.S. The training’s updated 2026 curriculum ensures alignment with both FDA and Health Canada expectations, making it ideal for organizations transitioning to the new regulatory landscape. By mastering integrated quality and risk systems, participants position themselves for advancement into leadership roles in regulatory compliance, quality assurance, and medical device lifecycle management.
What You'll Learn
Skills You'll Gain
Prerequisites
- Target Audience: Quality Engineers, Regulatory Affairs Specialists, Quality Managers, and Compliance Officers involved in medical device manufacturing.
- Required: Access to a personal copy of the ISO 13485:2016 standard document for reference during training sessions.
- Recommended: Foundational knowledge of medical device Quality Management Systems (QMS) and basic familiarity with ISO 13485:2016 structure and terminology.
- Recommended: Basic understanding of North American regulatory requirements, specifically FDA QMSR and Canadian Medical Device Regulations (CMDR/MDSAP).
- Recommended: Awareness of ISO 14971 risk management principles as applied to medical device development.
- Recommended: Practical experience with core QMS processes, including design controls, corrective and preventive actions (CAPA), and supplier management.
What's Included in Your Training
Every enrollment comes packed with resources to maximise your learning and exam success
Exam Preparation Materials
Practice Test Questions (200+)
Certificate of Completion
Post-Training Support (30 days)
Session Recording Access
Free Rescheduling (7+ days notice)
Career Outcomes
of ISO 13485:2016 – Introduction & Implementation with FDA QMSR (USA/Canada) — 2026 Update certified professionals report career advancement within 6 months
Salary Impact
Average salary increase reported after obtaining the ISO 13485:2016 – Introduction & Implementation with FDA QMSR (USA/Canada) — 2026 Update certification
*Source: Glassdoor / LinkedIn 2025
Job Roles
- Quality Management Systems (QMS) Lead
- Regulatory Affairs Specialist
- Medical Device Auditor
- Quality Assurance Manager
- Compliance Manager
- Supplier Quality Engineer
Companies Hiring
and 5,000+ organizations worldwide seeking ISO 13485:2016 – Introduction & Implementation with FDA QMSR (USA/Canada) — 2026 Update certified professionals
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“I trained 15 of my team members for SC-200. Koenig's on-site delivery was seamless and all 15 passed within 3 months.”
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“The 1-on-1 format was a game changer. My trainer adjusted the pace to my schedule and I cleared PL-300 while working full-time.”
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“Passed AZ-104 on first attempt. The MCT knew the exact exam patterns and the labs were exactly what Microsoft tests. Worth every penny.”
AZ-104 Certified ✓ Verified -
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“I trained 15 of my team members for SC-200. Koenig's on-site delivery was seamless and all 15 passed within 3 months.”
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“The 1-on-1 format was a game changer. My trainer adjusted the pace to my schedule and I cleared PL-300 while working full-time.”
PL-300 Certified ✓ Verified
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“From AZ-900 to AZ-305 in 6 months. Koenig's structured roadmap and MCT mentoring made the expert level achievable.”
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“SC-900 and SC-300 back to back — both cleared first try. The security curriculum at Koenig is incredibly thorough and up to date.”
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