Agile software development for medical devices

In today's constantly evolving healthcare industry, the development of medical devices, including medical software, requires a dynamic and flexible approach. One such approach is agile.

Agile is a software development methodology that emphasizes collaboration, iterative development, and quick response to change.

It has proven to be an effective way to develop medical devices that are safe, effective, and meet regulatory standards. This approach is especially useful in the development of complex medical devices that require frequent updates and modifications to meet changing market needs.

Agile enables developers to quickly prototype and test medical devices, identify potential issues early on, and refine them in a collaborative and iterative manner. This approach also allows for better quality control and faster time-to-market.

But is this approach compliant to regulatory requirements as stated by the US FDA and the legislation EU MDR?

In our online event, we discuss which relevant requirements for medical software can be implemented in an agile development environment and in what way, and how development teams can implement them.

We will have a focus on standard IEC 62304AM1 and learn how the US standard AAMI TIR 45 guides us on the use of agile practices in the development of medical device software.

Target audience:

Employees of medical technology companies, involved in the development of medical device.

Agenda:

14:00 Registration

14:15 Welcome and introduction

Hans Wenner, VDE

14:20 Application of IEC 62304 as part of agile software development

Hans Wenner, VDE

• Software development under IEC 62304: “how can this process be agile?”
• How VDE suggests implementing the principles of Risk Management, Quality Management and Software Engineering
• Presentation of this integrated approach, with a glimpse on documentation

15:00 Using TIR 45 to be agile in developing medical device software

Kelly Weyrauch, Agile Quality Systems, LLC (USA)

• Overview of AAMI TIR45: “Guidance on the use of AGILE practices in the development of medical device software”
• Executing the activities of 62304 in an Agile framework
• Demonstrating compliance – an Agile approach to documentation
• Satisfying regulators

15:45 Break

16:00 Agile development of medical devices with a very practical insight

Malte Bucksch, QuickBird Medical - QuickBird GmbH

• Symbioses of agile software development and medical device product specifications
• Tools and methods to seamlessly integrate processes into the familiar environment
• Advantages and disadvantages of different approaches
• Appropriate implementation of processes with Atlassian Confluence and Jira

16:45 Wrap-up

17:00 End

Vorläufiges Programm. Änderungen / Anpassungen vorbehalten.

Tentative schedule. Subject to changes / adjustments.

Tuition Fees

VDE Member*: 225 EUR
Non Member:  250 EUR

*Discount only with a VDE Membership