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.
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
The following topic will be addressed during this two days course:
- Regulatory considerations (EU and US rules and guidance)
- Software as a medical device
- IEC 62304 and other standards
- Key concept associated with IEC 62304
- Review of the standard requirement
- Compliant development process
- Software risk analysis
- Technical file and quality documentation
- Cybersecurity and medical device software
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
Dr. William Enns-Bray, Project Associate, Medidee Services SA
"I liked the material and the exercise"
"Good discussions, excercises and instructor"
"The trainer was very skilled within the topic and with a very good English"
"Good comprehensive course. Lots of good insights from the instructor"
"I liked the discussion of exercises"
Participants, Spring 2020