in Compliance With Regulatory Requirements
Online Event on October 5th, 2021> Register now
Agile software development has become the state of the art in many companies. Due to the more flexible style of development, sometimes the question arises, if it is too flexible to meet strict regulatory requirements for medical devices. The primary requirements, which should be met, arise from the European Medical Device Regulation (MDR) itself and from the international standard IEC 62304 on software life cycle processes.
So, is it true that an agile approach to software development for software being a medical device cannot be used in compliance with the MDR? The answer is: “No. This is not true.” You can use an agile approach. However, it is correct that many rules and standards were developed in the light of more classic, determined approaches of software development, but they are broad enough, to also fit the agile approach.
In this event we will have different views on (successful) agile medical software development. The consultants from VDE will grant a glimpse into a feasible solutions, how they suggest applying the IEC 62304 to an agile approach and to stay in conformance with MDR. Then, since a notified body will have to certify that all regulatory requirements are met, the notified body BSI will let us know about potential problem areas, differences in reviews and best practice. Dräger as a manufacturer has certainly developed their own approach and will let you know about the history of coming to the current way of working, their way of documenting and the challenges they have overcome.
This online event will be held in English.
The event will take place with a minimum of 8 attendees. If we cannot meet the minimum of 8 attendees 1 week before the event, we will have to cancel the event. So please, make sure to register latest 8 days before the event. Thank you.
|14:30||Applying IEC 62304 to an agile approach|
Hans Wenner, VDE
– Change is inevitable – so why stick to a rigid development process?
– The development process as described in IEC 62304: how can this process be “AGILE”?
– “AGILE development” is not synonymous to “Development Without any Planning”!
– How we (VDE) suggest implementing the principles of Risk Management, Quality Management and Software Engineering
– Presentation of this integrated approach, including a glimpse at documentation
|15:15||Agile Software Development for Medical Devices: A Notified Body’s Perspective|
Bryan Pourciau, BSI
– Best practices for documentation submission
– NB reviews of Agile SW submissions versus more traditional “Waterfall” SW submissions
– Regulatory accommodations needed for the “Agile Manifesto”
– Potential problem areas when applying an Agile methodology
– Related standards and guidance documents to consider
|16:15||Agile Development in a Regulatory Environment – a matter of culture|
Sina Scheuplein, Drägerwerk AG & Co KGaA
– Agile Software Development at Dräger
– Compliance with regulatory requirements
– Opportunities and Pitfalls
|17:00||Wrap up and closing comments|
|17:15||End of event|
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