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The one-day compact seminar aims to increase your competence in the practical implementation of regulatory requirements (in particular IEC 62304) while promoting efficient software development. You are responsible for the development or quality assurance of medical device software or software as a medical device (SaMD)? Then you should attend this seminar!
This seminar is a compact introduction to the topic of development, quality assurance and approval of medical software (software as a medical device or medical device software). It is especially aimed at those who want to get a quick and comprehensive overview of the following topics:
|09:00||Start of the seminar|
|09:30||Relevant standards, laws and directives and their interrelationships|
|10:00||Medical Device Regulation (MDR, 2017/745), National laws and regulations, Basic requirements according to Annex I|
|10:45||When does software become a medical device?|
|11:15||Approval procedures in Europe and USA|
|11:45||Overview IEC 62304, Software Requirements Specification (I)|
|13:30||Software Requirements Specification (II)|
|15:15||SOUP, security classification and interaction with risk management according to ISO 14971|
|15:45||Software development process, agile development|
|16:30||Deepening or/and desired topics of the participants e.g. differences to FDA requirements, or test documentation|
|17:15||Answering individual questions, typically until 18:00|
The seminar focuses on practical aspects. Participants learn to implement the requirements of IEC 62304 without QM bureaucracy.
The lectures alternate with case studies and exercises. We limit the number of participants to a maximum of 16 to ensure learning success and to have enough time for answering individual questions.
The seminar "Compliant medical device software development" is intended for all persons involved in the standard-compliant software development of medical devices, both standalone software and software that is part of a medical device. In particular