Blog

14 May

Posted at 11:33h in AI, Blog, FDA, Medical Devices, Quality Systems, Regulatory by
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The next installment in our blog series on Artificial Intelligence/ Machine Learning (AI/ ML) based Software as a Medical Device (SaMD) will cover points three and four of FDA’s proposed Total Product Lifecycle (TPLC) approach: modification after initial review and transparency and real-world performance monitoring. If...

10 May

Posted at 12:25h in AI, Blog, FDA, Medical Devices, Quality Systems, Regulatory by
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As part of our blog series on Artificial Intelligence and Machine Learning Medical Devices, this time we will discuss the FDA’s take on how modifications made to the software after its initial review will be addressed within the SaMD pre-specifications and Algorithm Change Protocol submitted by the manufacturer to the FDA as...

07 May

Posted at 13:18h in AI, Blog, FDA, Medical Devices, Quality Systems by
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As part of our blog series on artificial intelligence and machine learning driven medical devices, we discuss the SaMD Pre-Specification and the Algorithm Change Protocol that FDA has crafted for such devices, in this blog.  Before a medical device can be marketed in the U.S. it must be cleared or...

29 Apr

Posted at 13:48h in AI, Blog, FDA, Medical Devices, Quality Systems by
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FDA expects every medical device manufacturer to have a robust and compliant quality system. FDA has been taking great strides in establishing regulations for the digital health industry that also facilitates research and development while maintaining high quality products. In our previous blog: ARTIFICIAL INTELLIGENCE &...

09 Apr

Posted at 09:45h in Blog, FDA, Medical Devices, Quality Systems, Regulatory by
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Randomized controlled trials have long been the gold standard for collecting clinical data on investigational medical devices. However, with the increasing costs of conducting trials, difficulty in tracking long-term outcomes, and sometimes mismatch of clinical trial data with practical experience, medical device manufacturers are interested...