What Information FDA is Expecting for Cyber Devices?
In an era where medical devices are increasingly interconnected and reliant on software, cybersecurity has become a critical component
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Medical device software development requires deep regulatory, technical, and cybersecurity expertise. You can trust Bold Type to develop usable, beautiful, and functional software that is secure and meets FDA’s requirements.
Already have an engineering team? We can help you navigate the FDA’s latest cybersecurity requirements to avoid regulatory delays.
90% of medical device and digital health companies fail… because they encounter unexpected delays in a years-long process, which eat up additional capital.
77% of development costs are devoted to FDA related activities. Focused Ultrasound Foundation
Poor usability can delay FDA clearance and limit market adoption.
Tremendous knowledge and skill are needed to develop software that meets FDA's cybersecurity requirements.
FDA regulations and oversight are strict. The ability to quickly develop a product with the necessary documentation and testing is critical to a successful launch.
In an era where medical devices are increasingly interconnected and reliant on software, cybersecurity has become a critical component
While remote software updates for medical devices have traditionally been seen as a convenient feature, the FDA now emphasizes
A startup recently shared with us that they were considering incorporating remote software updates into their medical device. They
President
20 years of experience in medical device product development. PhD in electrical engineering and computer science from MIT.
Chief Software Architect
30 years of experience in cybersecurity and secure software development (embedded, mobile apps, cloud computing, etc.)
Chief Operating Officer
15 years of experience leading secure software development teams. Bachelor's in engineering, Master's degree in management from Harvard.
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