Are you responsible for the development or quality management of medical device software, either for (embedded) medical device software or for (stand-alone) software as a medical device (SaMD)? Is an audit pending? If so, you should attend the seminar! Here's how you will benefit from the seminar:
This seminar is a concise introduction into the topics of development, quality assurance and approval of medical software (stand-alone software or medical device software). It especially addresses everyone aiming at getting a quick and comprehensive overview of the following topics.
|09:00||Beginning of the seminar|
|09:30||Relevant standards, laws, regulations and their interactions|
|10:00||Medical Device Directive (MDD, 93/42/EC), Medical device regulation (MDR), national laws and regulations, essential requirements|
|10:45||When is software classified as a medical device?|
|11:15||Approval procedures in Europe and the USA|
|11:45||Overview of IEC 62304, Software Requirements Specification (I)|
|13:30||Software Requirements Specification (II)|
|15:15||SOUP/OTS, software classification, software risk management|
|15:45||Software development process, agile development|
|16:30||Additional FDA requirements, software verification and validation|
|17:15||Questions and answers session, typically until 18:00|
Paramount of this seminar is practical relevance. Participants will learn how to quickly fulfill requirements (e.g. IEC 62304, FDA) without creating a QM bureaucracy.
The lectures are alternating with case studies and exercises. We limit the maximum number of participants to 16 to ensure learning success and having enough time to respond to individual questions.
The seminar "medical software" addresses everyone involved in software development for medical devices complaint with standards, both regarding stand-alone software and software being part of a medical device. Addressed are especially
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Do you have any questions or suggestions? Do you want to carry out the seminar as an inhouse-seminar, to tailor the topics to your individual needs? Contact us directly. We are looking forward to it!