IEC 62304 – The unique aspects of Software as a Medical Device
Do you want to develop innovative medical device software? Do you want to avoid wasting time on rigid processes and instead make your development process efficient while ensuring compliance with standards?
In this seminar, learn the fundamental concepts behind IEC 62304 to improve the quality of your development. Regardless of the methods you use to develop your software, we’ll show you – with many illustrative examples and practical tips – how to apply the regulatory requirements of IEC 62304 to your company and products.
- Content
- IEC 62304 in the Context of Other Relevant Standards
- Agile vs. Waterfall: The Different Methods of Software Development
- Structure and Organization of IEC 62304
- Classification of software as a medical device
- Risk management for software: Cyber and product security as part of the development process
- Processes in the software lifecycle: The role of software specification and architectural design throughout the lifecycle
- Your Benefits
- With the knowledge gained in this seminar, you will be able to efficiently design your development processes.
- You will gain a clear and easy-to-understand overview of the regulatory requirements for the development of medical device software.
- You can use the interactive exercises to address your specific questions and exchange experiences with other seminar participants.
- You will receive practical solutions for your company and inspiration for your day-to-day development work.
- Methods
Presentation, workshops, real-life examples, discussion, storytelling
- Target Audience
- Medical device developers
- Project managers
- Managing directors
- Quality management specialists
- Regulatory affairs managers
