Resources
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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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Top 5 FDA Cybersecurity Tips
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How Resilience Accelerated Regulatory Maturity with BeanStock Venture’s Fast Track Model
Summary Resilience, a biomanufacturing innovator, faced the challenge of building regulatory maturity for full clinical development from assay, automation, devices…
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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 A Global Therapeutics Manufacturer needed a secure, scalable data portal to analyze and manage chemistry analyzer results across its…
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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…