Summary
Key results
More than 50 employees trained
Improved understanding of the standard’s procedures and their practical application
Applying medical device software requirements in practice
The client wanted employees involved in medical device software development to develop a stronger working knowledge of IEC 62304 and how its procedures applied to their work. The training also needed to incorporate relevant aspects of ISO 13485 and ISO 14971, expanding their knowledge of compliance, risk management, and quality assurance requirements.
The need went beyond theoretical knowledge. Employees needed to relate the requirements to projects they were already working on so they could apply the procedures more effectively and support better software and documentation quality in future projects.
To address this need, the client selected Sii Poland to deliver focused training grounded in participants’ project experience.
Interactive training based on active project questions
Sii Poland delivered a training session focused on the most important aspects of IEC 62304. The content also incorporated key elements of ISO 13485 and ISO 14971 related to compliance, risk management, and quality assurance in medical device software development.
The session combined presentation with open discussion. Participants could ask specific questions about projects they were actively working on, helping them understand how IEC 62304 applied to their own work.
Better application of IEC 62304 in future projects
The training strengthened the understanding of IEC 62304 and its procedures among more than 50 employees. Participants are now better equipped to apply the standard’s requirements more effectively in their work.
This improved knowledge is expected to support higher-quality software and documentation and contribute to better outcomes in future projects.
Key results
- More than 50 employees trained in IEC 62304
- Improved understanding of IEC 62304 procedures and their application in project work
- Broader knowledge of medical device software development through relevant aspects of ISO 13485 and ISO 14971
- Stronger basis for improving software and documentation quality in future projects
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