Implementation of the software standards IEC 62304 and IEC 82304-1 for manufacturers of medical devices

Produktnummer 08-089-25

Training Präsenz / Virtuell
2 days
Beginner

Details

The IEC 62304 and IEC 82304-1 standards will be presented in a practical way during the seminar. The implementation of these software standards is a challenge for many manufacturers of medical devices, as a number of processes are required. The seminar provides a basic overview of the essential content of the standards and the required processes that describe the software life cycle. Practical exercises will deepen the handling of the standards and the implementation in terms of process design and documentation will be practiced. The aim of the seminar is to learn the requirements for the development and approval of medical software and to be able to implement them for your own application.

Vorteile | Advantages

You will acquire in-depth knowledge of the IEC 62304 and IEC 82304-1 software standards.
You will know how to implement the IEC 62304 and IEC 82304-1 software standards in your company.
You will gain know-how on how to optimize medical software development processes.

Inhalte | Content

Terms and definitions
Requirements of the software standards IEC 62304 and IEC 82304-1
Software security classification
Software development process
Software maintenance process
Software risk management process
Software configuration process
Software problem solving process
Methods of verification
Integration with other standards and validation
Implementation of the standard in existing medical software
Practical development of important aspects of the standard through group work and workshops

Hinweis | Note

The contents of the seminar correspond to the current state of revision/harmonization.
The seminar deals with internationally valid standards and is also suitable for implementation abroad.
This seminar is part of a modular training program. After successful participation in the further modules, you can acquire this recognized qualification:
Specialist Medical Software - TÜV Foundation Level

Duchführende Akademie | Executing Academy

All online sessions of this event are conducted by TÜV SÜD Akademie GmbH in Germany. Therefore, for online trainings, the General Terms and Conditions, Examination Regulations, and Data Protection Information of TÜV SÜD Akademie GmbH also apply. If you have any questions, please feel free to contact us at [email protected].

1.389,00 €Nettopreis

1.666,80 €Bruttopreis

Preisdetails einblenden

Nettopreis1.389,00 €

20% USt.*277,80 €

Bruttopreis1.666,80 €

*Kann außerhalb von Österreich abweichen

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Wie können wir helfen?

+43 5 0528 3030

[email protected]