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Successful Development, Approval and Deployment of Digital Health Solutions

Leave a Comment / Compliance Management, connected care, Digital Health, end user, Focus Article, Health Data, interoperability, Manufacturing Execution, Medical Device, MedTech, Quality/Regulatory, RC - Device Design & Manufacturing, regulatory compliance, software design / By

Successful Development, Approval and Deployment of Digital Health Solutions     For life sciences companies seeking to develop, deploy and successfully commercialize digital health products and solutions, the pathway to success can have many twists and turns, and be littered with false starts, roadblocks and more than a few misdirections. The pace of technological development—which is …

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FDA Releases Final Guidance on Premarket Submissions for Device Software Functions

Leave a Comment / Digital Health, Final Guidance, Medical Device, medical device software, MedTech, premarket submissions, Quality/Regulatory, RC - Medtech Regulatory Resource Center, software design / By

FDA Releases Final Guidance on Premarket Submissions for Device Software Functions     The FDA has released a final guidance on premarket submissions for device software functions. “Content of Premarket Submissions for Device Software Functions” covers recommended documentation sponsors should include in premarket submissions for FDA’s evaluation of safety and effectiveness of device software functions. This …

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