Workshop

Medical Software, Workshop - Online Event on October 5th, 2021

Agile Development of Medical Software

Is it true that an agile approach to software development for software that is a medical device cannot be used in compliance with the MDR? The answer is: “No. This is not true.”
Find out more in our online workshop.

Head with Gear Wheels symbolizing AI (Artificial Intelligence) Head with Gear Wheels symbolizing AI (Artificial Intelligence)
Artificial Intelligence, Workshop - Online Event on June 22, 2021

Regulatory Affairs for AI Applications in Medical Devices

The use of AI blurs the determination of classic software products because the training data alters the algorithm. Hence, all stakeholders are facing new challenges: the potentially continuing modifications as well as being very much depended on carefully selected training data. Therefore, currently AI algorithms need to be implemented in a frozen state in medical devices to receive clearance for US or EU market access.