Category: Blog
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5 Ways to Catch Medical Device Software Defects Before They Become Costly Problems
Medical device software defects become more expensive the longer they go undetected. From design and risk analysis to testing, deployment, and post-market feedback, teams have opportunities throughout the product lifecycle…
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Shawnnah Monterrey: Guiding Innovative Healthcare Products to Market
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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…