AVA Women wants to enhance their fertility tracing bracelet so it can be used for other indications. Zühlke supports AVA Women in the process of setting up the required regulatory compliant machine learning solution.
Review and improvement
AVA Women wants to extend the functionality of their fertility tracing bracelet so that it can also be used for other indications. Thus, AVA’s machine learning-based algorithm is becoming a class IIb medical product and requires approval by a notiﬁed body. AVA Women wants to ensure that machine learning development fulﬁlls the regulatory needs and asks Zühlke to review and improve their processes.
Workshops on site
Zühlke’s medical software and regulated machine learning experts organize reviews to analyze and evaluates the status of the processes. Based on Zühlke’s experience in the ﬁeld of regulated machine learning and the review ﬁndings, pragmatic solutions and improvements are developed during workshops with the teams at AVA.
With a reasonable and limited effort, the Teams at Zühlke and AVA can conﬁdently conﬁrm the adequacy of the path that AVA has taken. Together, inputs are evaluated, and improvements are implemented to guarantee compliant machine learning in medical software. The changes have been incorporated into AVA’s process landscape and will be used for future developments.