IEC 62304: Software Lifecycle
This training aims to bring a complete overview of the implementation of the IEC 62304 for the development of a software as a medical device. The regulatory context will be discussed, the integration of software aspects within a medical device are reviewed and all aspects associated to IEC 62304 will be presented in order to be able to implement a compliant software development process.
Course objective and outcome
This training aims to bring a complete overview of the implementation of the IEC 62304 for the development of software as a medical device. The regulatory context will be discussed, the integration of software aspects within a medical device are reviewed and all aspects associated to IEC 62304 will be presented in order to be able to implement a compliant software development process.
The main objectives are:
- Present the key concepts related to the development of software for a medical device
- Identify medical devices when working with a standalone software
- Present all requirements associated with IEC 62304
- Present the necessary modifications in the Quality Management System in order to sustain a software development process compliant to IEC 62304
- Review recommended verification and validations activities for software development
- Present a documentation structure and content to be included in a Medical Device Technical Documentation prepared for regulatory submission
Content
- General overview of the standard series including structure and relations
- How to use and interpret the standard series
- Relation to legislation in Europe and around the world
- Safety philosophy
- Risk analysis
- Requirements for construction and test methods
- Review of §4-17 in basic standard EN 60601-1
- Systems
- Usability
- Hands-on training exercises
Who should attend
- Quality Manager to understand the impact of the standards on their QMS
- Design and software engineers to understand the expectation of the IEC 62304 with regards to the development process
- Team leaders and product managers to understand how requirements related to IEC 62304 affects their design team
- Risk Managers to integrate risk classification and software risk identification aspects in their process
- Anyone who is interested to understand the requirements associated with software on medical device development and validation
Trainer
TBA
What previous participants said
Contact
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18-19.06.202617-18.12.2026
18-19 June 2026 - at 09:00 - 16:00
Price ex. VATLatest Registration
11.06.2026
Latest Cancellation
28.05.2026
Bøge Allé 5, 2. th
2970 Hørsholm
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Terms
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Berit Munkebo
Head of Development
bm@medicoindustrien.dk
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