FDA QMSR – Introduction to the new regulation in the US
May 23, 2024 1:00 pm - 4:30 pm
FDA QMSR – Introduction to the new regulation in the US
FDA QMSR – Introduction to the new regulation in the US
Half day course – Online
Learn more about the implementation of FDA´s new Quality Management System Regulation (QMSR) and what marketing approval in US requires after February 2, 2026.
Topics
FDA Quality System Regulation, Manufacturer 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 Leader
Ferenc Dahnér, Senior Quality and Regulatory Consultant.
SIGN UP»
Event details
Date & Time
FDA QMSR – Introduction to the new regulation in the US
May 23, 2024 1:00 pm - 4:30 pm
Location
Organizer & Venue
FDA QMSR – Introduction to the new regulation in the US
Organizer QAdvisPrice SEK3900
URL: View Events Website
Privacy Preferences
This website uses cookies to enhance your experience. Some are essential for site functionality, while others help us analyze and improve your usage experience. Please review your options and make your choice.
If you are under 16 years old, please ensure that you have received consent from your parent or guardian for any non-essential cookies.
Your privacy is important to us. You can adjust your cookie settings at any time. For more information about how we use data, please read our privacy policy. You may change your preferences at any time by clicking on the settings button below.
Note that if you choose to disable some types of cookies, it may impact your experience of the site and the services we are able to offer.
Essential cookies and services enable basic functions and are necessary for the proper functioning of the website. These cookies and services do not require user permission according to GDPR.
cookieyes-consent
et-editor-available-post-*
et-pb-recent-items-colors
et-pb-recent-items-font_family
mhcookie
wordpress_logged_in_*
wordpress_test_cookie
wp_lang
wp-settings-*
wp-settings-time-*
ideon.se
www.ideon.se
Statistics cookies collect usage information, enabling us to gain insights into how our visitors interact with our website.
_ga (kept for: at least one session)
_ga_* (kept for: at least one session)
ajs_anonymous_id (kept for: at least one session)
b-user-id (kept for: at least one session)
Marketing services are used by third-party advertisers or publishers to display personalized ads. They do this by tracking visitors across websites.
_gcl_au (kept for: at least one session)
This category includes all cookies, domains, and services that do not fall into the other specified categories or have not been explicitly categorized.
amp_* (kept for: at least one session)
cbLDBex (kept for: at least one session)
cookiesEnabled (kept for: at least one session)
dvmd_accessibility_sidebar_settings (kept for: at least one session)
et-editing-post-* (kept for: at least one session)
et-recommend-sync-post-* (kept for: at least one session)
et-saved-post* (kept for: at least one session)
et-saving-post-* (kept for: at least one session)
MicrosoftApplicationsTelemetryDeviceId (kept for: at least one session)
MicrosoftApplicationsTelemetryFirstLaunchTime (kept for: at least one session)
notified-Affichage_Charte (kept for: at least one session)
sc_clearance (kept for: at least one session)
ssm_au_c (kept for: at least one session)
Consent date:
Device id:
Some required resources have been blocked, which can affect third-party services and may cause the site to not function properly.