Medical devices are becoming increasingly complex with rapid advancements of their software and Artificial Intelligence (AI) acting as a smarter ‘brain’ behind their hardware. The advancements of medical device software and a new clause from the Medical Device Regulation (MDR) has seen the industry face increased regulatory scrutiny and caused unique challenges such as, different regulatory demands across countries, ever-changing guidelines and a lack of consensus between manufacturers. In the face of such challenges, compliance and quality assurance of medical device software is more important now than ever before.

Ahead of this year's Software Design for Medical Devices event, this infographic explores the current compliance and regulatory issues facing medical device software and provides solutions to help industry professionals maintain regulatory compliance.

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