The events of the COVID-19 pandemic have rapidly accelerated the rate of medical device software development to meet unmet clinical needs and bridge the gap in healthcare delivery that the global public health emergency has created. As complex algorithms and Artificial Intelligence (AI) are now being incorporated into an ever-increasingly large number of medical devices and health technologies, companies are under enormous pressure to ensure not only the clinical effectiveness of their medical device software, but also to take advantage of the accelerated adoption of these technologies to help them to stay one step ahead of the competition. In the face of such pressure, building resilience and agility to maximise the speed of your software development, whilst maintaining compliance are more important now than ever before to survive and thrive in this digital age.
Ahead of the 10th Annual Software Design for Medical Devices Global Forum, we spoke exclusively to Patrick Alff, Founder of Ezthera, and John Mulcahy, Vice President Product at S3ConnectedHealth, on all things digital healthcare, and go into detail about the impact of the pandemic, the risks and opportunities, and the future of digital healthcare for software-enabled medical devices or Software as a Medical Device (SaMD).
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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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