Seminar FDA’s Quality Management System Regulation 

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 (QMSR) in detail. We will show you 

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

Since ISO 13485 is a large part of the QMSR's content, the seminar will discuss and analyze all ISO 13485 requirements. We will also highlight additional FDA requirements.

The seminar is, therefore, aimed at people who have little or no knowledge of ISO 13485 or who want to improve and deepen their existing knowledge.

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:

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.