Category: Blog
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2023 Predictions for Medical Device Product – Jama Software
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2021 Predictions for Medical Device Product and Systems Development
2020 has been a year that’s been described as “unprecedented” and “unparalleled” – as well as other descriptors probably best…
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Does Your Medical Device Software Need Help?
Medical Device Software Development has evolved significantly since medical devices have gone online. Gone are the days of being able…
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Monetize Software: Leverage Your Software to Fill the Supply Chain Revenue Gap
The current supply chain difficulties are impacting revenue for many organizations, including General Electric Co.1 As product roadmaps are being…
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Top 5 FDA Cybersecurity Tips
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Tips for selecting the right software development partner
The skill of a software engineering team is vital for optimizing the economics of a software product over commercial time scales. …
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Tips to reduce the risk of a cybersecurity breach
On December 28th, 2010 FDA issued industry guidance for Postmarket Management of Cybersecurity in Medical Devices. FDA requires that medical…
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How to Determine if Your Product is a Medical Device
The FDA considers a product to be a device, and subject to FDA regulation, if it meets the definition of a medical device…