Learn more about the implementation of FDA´s new Quality Management System Regulation (QMSR) and what marketing approval

ISO 13485:2016 will largely replace the requirements of the current QSR but with some additions and clarifications. The new Quality Management System Regulation (QMSR) also includes several new sections. It’s important to note that certain other US medical device regulatory requirements will remain unchanged.

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

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 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.