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In an era where medical devices are increasingly interconnected and software-dependent, cybersecurity has become a critical component of healthcare. The FDA recognizes the importance of
While remote software updates for medical devices have traditionally been seen as a convenient feature, the FDA now emphasizes their crucial role in safeguarding against
A startup recently shared with us that they were considering incorporating remote software updates into their medical device. They knew this feature would add a
In the bustling healthcare landscape, the mHealth market—estimated between $50 billion and $110 billion USD in 2022—is more than just a promising niche. Given the
In today’s competitive and fast-paced market, efficiency and lean operations are essential. For startups and small businesses, setting up a full-fledged Quality Management System (QMS)
Implementing a Quality Management System (QMS) for a medical device startup is not just an exercise in regulatory compliance; it’s a foundational step to ensure
