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