ISO 13485:2016 – Introduction & Implementation with FDA QMSR (USA/Canada) — 2026 Update
 | Disponible en Español | Also available in Spanish |
This course is certified by Exemplar Global.
Updated for USA FDA QMSR 2026 & Canada CMDR/MDSAP
ISO 13485:2016 continues to be the internationally recognized foundation for quality management systems in the medical device industry. With major regulatory changes in North America, this course has been fully updated to reflect:
- The U.S. FDA Quality Management System Regulation (QMSR) replacing the legacy QSR and aligning 21 CFR 820 with ISO 13485:2016 (effective Feb 2, 2026)
- Transition to ISO‑aligned terminology, including the Medical Device File (MDF) replacing DHF/DMR/DHR under QMSR
- Expanded FDA access to management review, internal audits, and supplier audits
- Canadian requirements under the Canadian Medical Devices Regulations (CMDR) and MDSAP (mandatory for Class II–IV MDL holders)
This interactive course introduces the structure, intent, and application of ISO 13485:2016 and provides clear guidance on how to implement the standard within your organization. The training includes practical workshops, North America–specific regulatory expectations, and hands‑on implementation exercises to prepare teams for compliance across global markets.
During this two‑day training, you will:
- Gain foundational knowledge of the structure and key requirements of ISO 13485:2016
- Understand how to embed quality and risk‑management principles into operational and support processes
- Explore strategies for mapping standard requirements to existing business workflows
- Apply learning through an implementation workshop focused on integrating ISO 13485 elements into real-world organizational processes
The course provides an excellent starting point for teams preparing to establish, enhance, or align their quality management system with the ISO 13485:2016 standard.
Course Testimonial: "The course was very clear and informative. I highly recommend it to all who work in an organization which is ISO 13485:2016 certified."
Important: TÜV SÜD tests and certifies through its Notified Bodies medical devices and their manufacturers. TÜV SÜD Akademie GmbH offers trainings in the field of medical devices.
The neutrality and independence of the conformity assessment procedures carried out by TÜV SÜD must be maintained. In the interest of our customers, hence the seminars of TÜV SÜD Akademie do not contain any product-specific, process-related or company-specific content or solutions that could fulfill the function of individual consulting.
In case of any questions or uncertainties, please do not hesitate to contact us at [email protected].
This training is ideal for:
- Medical device manufacturers, suppliers, and service providers
- Quality Management Officers (QMOs), Quality Engineers, Regulatory Affairs professionals
- Product Managers, R&D, operations, and compliance teams
- Consultants supporting ISO 13485, QMSR transition, CMDR/MDSAP compliance
- Organizations preparing for ISO 13485 certification or updating their QMS for QMSR 2026
- Regulatory & Normative Foundations
- ISO 13485:2016 structure & intent
- Global regulatory landscape (EU MDR overview, U.S. QMSR, Canada CMDR/MDSAP)
- Lifecycle of a medical device
- U.S. QMSR (21 CFR 820) — Effective February 2, 2026
- Alignment with ISO 13485:2016
- FDA‑specific retained requirements (UDI, MDR, C&R, Tracking)
- MDF vs legacy DHF/DMR/DHR
- FDA inspection posture: MR / Internal Audits / Supplier Audits
- Canada — CMDR & MDSAP Essentials
- Licensing pathways (MDEL, MDL, MDSAP)
- Labeling & bilingual requirements
- PMS, incident reporting, recalls, summary reports
- Health Canada expectations for audits
- ISO 13485:2016 in Detail
- Quality management system structure
- Documentation requirements & the MDF
- Design & development controls
- Purchasing & supplier management
- Production & process controls
- Cleanliness, installation, servicing, sterilization
- Monitoring, measurement & improvement
- Risk Management (ISO 14971)
- Risk analysis
- Risk control mapping
- Integration into design, production & PMS
- Hands‑On Implementation Workshop
- Process mapping
- Practical exercises
The program is designed for professionals who wish to gain a solid understanding of the fundamental requirements of ISO 13485:2016 and explore practical approaches for implementing the standard within their organization.
ISO 13485:2016 serves as the cornerstone of quality management systems for the medical device industry and its supply chain. The standard outlines essential requirements for manufacturers, emphasizing the importance of comprehensive process‑based risk management. These risk‑management activities must be integrated across all quality‑related processes, including those performed by external suppliers.
Beyond product development and manufacturing, ISO 13485:2016 also requires organizations to address processes that occur after medical devices are placed on the market, ensuring ongoing safety, effectiveness, and regulatory compliance throughout the product lifecycle.
At the end of this course, participants will be able to:
- Master the structure & intent of ISO 13485:2016
- Understand clauses, terminology, and lifecycle integration
- Learn risk‑based process controls required throughout the product lifecycle
- Apply ISO 13485 in the context of new U.S. & Canadian requirements
- Understand how QMSR incorporates ISO 13485 and ISO 9000:2015 terms
- Identify the FDA‑specific retained requirements:
- UDI (21 CFR 830)
- Medical Device Reporting (21 CFR 803)
- Corrections & Removals (21 CFR 806)
- Device Tracking (21 CFR 821)
- Understand Canada’s regulatory framework
- CMDR requirements for quality, PMS, incidents, recalls, summary reports
- Licensing distinctions: MDEL (Class I) vs MDL + MDSAP (Class II–IV)
- Labeling requirements including bilingual (EN/FR) obligations
- Implement and audit ISO 13485 requirements within your QMS
- Apply risk management (ISO 14971) and traceability per §§7.3 and 7.5.8/7.5.9
- Build and maintain the Medical Device File (MDF)
- Prepare for FDA and Health Canada expectations in internal audits
- Map ISO 13485 requirements into existing organizational processes
TÜV SÜD has achieved Exemplar Global Accreditation as a Recognized Training Provider. This accreditation confirms our commitment to providing the highest quality services and demonstrates our expertise in our industry.
As a professional, it's important to have recognition for your skills and knowledge. Exemplar Global Accreditation provides this recognition, giving you a competitive edge in the marketplace. With over 30 years of experience building certification programs, Exemplar Global is the leading authority in accreditation for the conformity community.
As a student of an Exemplar Global Recognized Training Provider (RTP) course, you are eligible to receive:
- Access to Exemplar LINK
- 12-months of exclusive benefits including:
- One self-coaching assessment
- Extended learning content
- Complimentary access to online events, online magazine, newsletters, and low-cost professional liability insurance
- Access to an exclusive LinkedIn Community
- The chance to look into alternatives for employment and career advancement
- A TÜV SÜD / Exemplar Global Graduate Certificate
At TÜV SÜD, we believe in maximizing your career and providing you with the tools you need to succeed. Our Exemplar Global Accreditation is a testament to our commitment to excellence and our commitment to helping you succeed.
Learn more about TÜV SÜD's Exemplar Global Accreditation today
This online instructor-led seminar addresses internationally valid standards. The contents of the seminar correspond to the current status of the revision/harmonization.
- Live instructor-led virtual classroom
- Real‑time Q&A, examples, case studies
- Group discussions & problem‑solving
- Quizzes and applied learning
- Course delivered by one of TÜV SÜD's leading industry experts
- Small class sizes enhance trainer-delegate relationship
- Receive globally recognised TÜV SÜD certificate upon completion
Instructor-led training in a virtual classroom means the course is Live Online. Participants will learn through online teaching. Lectures, case studies, group exercises, discussions, problem solving, examples with explanation, assignments and/or quizzes happen in the virtual classroom training. Participants need to connect to the class from any internet accessible location. Each module is delivered live using webinar technology, creating a virtual classroom learning environment. Live sessions provide you with direct access to the trainer so you can ask questions, understand complex concepts and share ideas with peers. Webcam and microphone are REQUIRED to interact with the instructor and/or other participants.
The course content and structure are designed by the domain experts from TÜV SÜD. With immense experience and knowledge in the relevant standards, our team of product specialists and technical experts at TÜV SÜD, developed the course content based on current business landscape and market requirements.
Certificate of participation from the TÜV SÜD Academy.
Included in the training price is the standard e-book "Quality Management and Risk Management for Medical Devices" (ISO 13485 and ISO 14971)
What’s New in This Updated Training?
- New U.S. FDA QMSR module (effective 2026)
- North America Summary chapter: QMSR vs CMDR/MDSAP vs ISO 13485
- Terminology updates: MDF replacing DHF/DMR/DHR
- New traceability walkthrough (Design → Field)
- Updated examples for:
- internal audits
- management review
- complaint handling & vigilance
- supplier controls
- Expanded Post‑Market Surveillance content
- Updated agenda reflecting all new regulatory harmonization