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
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

  
Trainer
Medidee Services SA

"Very competent instructors, good content coverage and framing into regulatory context"

"Overall a good and complete run through of the standard"

"Very competent lecturers. Good introduction to software development according to IEC 62304. Relevant "level" of course, not too detailed, but not too generalized either"

"I liked the specific advice on software testing and automation of tests"

"It gave a sufficiently in-depth introduction to the   
IEC-62304 standard and how to implement it"

Participants, Fall 2021