Seminar FDA’s Quality Management System Regulation 

Learn about the new regulation in detail to optimally prepare your quality management system 

This seminar will help you to understand the FDA's new requirements for your quality management system (QMS). You will learn what changes there are with regard to harmonization with ISO 13485:2016 and how to implement them in your company successfully. 

Next Seminar

FDA’s Quality Management System Regulation
Speaker: Claudia Volk
Location: Online Seminar
Language: English
Seats available
Your Price
880 €
plus VAT.
1047,20 € (incl. VAT.)

Gain clarity on which elements your quality management system must contain in the future 

You will learn about the requirements of the new Quality Management System Regulation in detail. We will show you 

  • how the QMSR is structured, 
  • how it relates to ISO 13485, and 
  • what the specific requirements are.

As ISO 13485 makes up a large part of the content of the QMSR, we will spend a considerable part of the seminar analyzing its requirements.

Learn how to implement the FDA requirements in your company efficiently and on time 

The seminar does not consist of purely frontal teaching sessions but lives from interaction and working through the requirements from the original text. Our experts will show you how to correctly interpret the regulatory and normative requirements and derive the necessary tasks from them. 

Benefit from our many years of experience to streamline your quality management system 

Our lecturers have many years of experience and in-depth knowledge in the implementation, optimization, and auditing of various QMS and can, therefore, give you valuable tips on how to cleverly combine all the requirements relevant to you and implement them in a lean and even beneficial way. 

You can find the exact learning content as well as the schedule of the seminar in the agenda:

Download Agenda (PDF)

Note: This seminar is intended for companies that have little or no experience in dealing with the ISO 13485 requirements or want to refresh their knowledge in this area. The additional QMSR requirements will be addressed.



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