Resources
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From Research to Clinical Platform: Agilent Achieves End-to-End Software Integration in 6 Months
Summary Agilent Technologies (via its acquisition of Lasergen) partnered with BeanStock Ventures to transform a manual engineering control tool into…
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Enterprise Speed Meets Clinical-Grade Standards: Rapid Deployment of a Custom Chemistry Data Platform
Summary Zoetis, the global leader in animal health, needed a secure, scalable data portal to analyze and manage chemistry analyzer…
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From Submission to Clearance in 60 Days: How Medical Templates Fast-Tracked FDA Approval with 3P510(k)
Summary Medical Templates AG, a Swiss-based MedTech innovator, had a strong internal team, an established QMS, and a well-prepared FDA…
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“The 10 Most Influential Women Making a Difference in Healthcare 2021” Beyond Exclamation Magazine
Congratulations to our amazing CEO, Shawnnah Monterrey for her recognition as one of the ’10 Most Influential Women Making a…
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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…