QM requirements in the USA (Quality System Regulation) @ ONLINE

The US market is one of the most important world markets for medical products. All medical devices that are to be marketed in the USA must meet the strict requirements of the US Food and Drug Administration.

In this seminar you will get to know the quality management standards according to 21 CFR 820 of the FDA as a prerequisite for the successful market access of your medical devices in the USA as well as the differences to ISO 13485:2016. Our USA expert will show you how to design your QM system in such a way that all the different requirements are met and you can successfully pass FDA inspections.

target audience
The seminar is aimed at approval officers, quality management officers and employees in the areas of quality management and clinical affairs as well as specialists and executives from medical device manufacturers who want to export to the USA.
This basic course is also suitable for participants with little previous knowledge, ISO13485:2016 - knowledge is an advantage.

trainer
Cornelia Luban, Senior Consultant, Qserve Group Germany GmbH