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New UK Medical Device Regulations are Coming: Here are 5 Ways Your Company Should Prepare

Over the next couple of months, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) is expected to roll out new guidance that will alter the way medical device products are regulated. Preparing for this change may be...

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Tags: regulatory, medical device, medical device regulations, UK, UK regulations

2021's Biggest Trends for Medical Device Companies

2021's Biggest Trends for Medical Device Companies

Twenty-twenty was a highly impactful year for the medical device industry, primarily due to the challenges brought on by the COVID-19 pandemic. As we move into 2021, there are even more changes on the horizon. This article will discuss four...

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Tags: covid-19, medical device, medical device trends, 2021 industry trends

FDA's Approach to Regulating AI Software for Medical Device Companies

FDA's Approach to Regulating AI Software for Medical Device Companies

Artificial Intelligence (AI) and machine learning are the newest technologies revolutionizing the medical device industry. These advances have the potential to transform the way medical device companies gather important insights from the vast...

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Tags: FDA compliance software, medical device document control, AI, Artificial Intelligence, medical device