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    Medical devices

    What is required for market access in the US after the new FDA QMSR?

    This half-day online course provides a practical overview of the FDA's new Quality Management System Regulation (QMSR) and what marketing approval in the US requires after February 2, 2026.
    ISO 13485:2016 will replace the requirements of the current QSR 820 but with several FDA additions and clarifications. Additionally, while ISO 13485:2016 forms the backbone of the new Quality Management System Regulation (QMSR), additional FDA-specific requirements still apply.

    This course aims to provide a comprehensive overview of all applicable requirements for non-US manufacturers seeking marketing approval for medical devices in the US following the implementation of the new QMSR.

    Topics

    • Overview of the Quality Management System Regulation
    • New and retained FDA-specific requirements
    • Manufacturer registration requirements
    • Device registration requirements and options
    • Post market requirements

    Trainers

    Ferenc Dahnér
    Ferenc Dahnér
    Senior Quality and Regulatory Consultant
    Ferenc has a clinical background and more than 25 years of experience in Quality and Regulatory Affairs. He has held senior roles including QA/RA Manager and PRRC and has guided multiple startups from early development through full EU MDR compliance. His expertise covers product development, risk management, usability engineering, and global regulatory requirements for both traditional medical devices and SaMD. Ferenc is known for quickly understanding complex challenges and identifying clear, practical, and least-burdensome regulatory solutions. He is a highly appreciated lecturer and has authored numerous well-received articles on medical device QA/RA.

    Target group

    Quality/Regulatory managers, design engineers, quality engineers, and others who have direct responsibility for medical device manufacturing, development and improvement. Prior knowledge about ISO 13485:2016 is recommended. Prior knowledge of QSR 21 CFR part 820 is beneficial but not required.

    Objectives

    After the course, participants will have an understanding of QMSR and its relation to ISO 13485:2016 and will be able to provide a roadmap outlining the necessary areas to target for successfully entering the US market.

    Additional information

    The course costs 3 900 SEK (excluding local VAT). Course material will be in English, verbal presentation and discussions varying between Swedish and English. 

    Related courses

    Quality management system according to EN ISO 13485:2016 – in practice
    The two-day course, in cooperation with Intertek Academy, provides a basic understanding of the requirements and how to design, deploy and maintain a working quality management system.