What is required for market access in US after the new FDA QMSR?
Half day course – Online
This course provides a practical overview of FDA´s new Quality Management System Regulation (QMSR) and what marketing approval in 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.
Target Group
Quality/Regulatory managers, design engineers, quality engineers, and others who have direct responsibility for medical device manufacturing, development and improvement.
Educational goals
Gain an understanding of QMSR and its relation to ISO 13485:2016 and provide a roadmap outlining the necessary areas to target for successfully entering the US market.
Recommended prior knowledge
Knowledge about ISO 13485:2016. Knowledge of QSR 21 CFR part 820 is beneficial but not required.
Course presentation
Course material will be in English, verbal presentation and discussions varies between Swedish and English. The information can be found beside the course date.
Course Leader
Ferenc Dahnér, Senior Quality and Regulatory Consultant.
Dates and location
Online course
3 December, (English)
08.30 – 12.30
Prices
Half-day course: SEK 3 900:-
All prices excl. local VAT.
Registration
For information and/or registration send your inquiry to QAdvis Academy.
Terms
Cancellations must always be communicated to Academy@qadvis.com and confirmed by us. Cancellations made more than 4 weeks before the starting date are free of charge. Cancellations made 4–2 weeks before the starting date of the event will be refunded by 50%. Cancellations made less than 2 weeks before the starting date of an event will not be refunded. If you are unable to attend, substitution with a colleague is possible and recommended.
QAdvis reserves the right to cancel the course due to low attendance, up until 2 weeks before the course start. You can contact us at any time to get a status update. If the course is cancelled, a full course fee refund will be offered, but no additional reimbursements. We reserve the right to change the agenda, time and location, up until 2 weeks before the course.
Force majeure
QAdvis reserves the right to change teachers or reschedule the course due to force majeure or due to teacher’s illness. No compensation will be paid for any additional costs incurred.
QAdvis is now officially part of Aurevia. This change of name follows our company’s integration into Aurevia. The Aurevia brand was born in January, when Labquality, Artimed, Clinical Consulting, Kasve, and Prisma CRO merged under the same name. With QAdvis now proudly joining the team, we are further strengthening our expertise and services and together offering greater value to our joint customers. Scandinavian CRO is also joining Aurevia.
