White Papers

Thought Leadership on SaMD, DTx & Connected Device Systems

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White Paper

White Paper: Developing Successful Software as a Medical Device (SaMD) at Speed

eBook

eBook: Digital Therapeutics (DTx): Accelerating Success Using Fast Feedback Loops

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White Paper: AI & Medical Devices

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White Paper: Product Analytics for Software as a Medical Device

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White Paper: Frequent Releases of Medical Devices

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White Paper: Digital Health and SaMD Lessons Learned from 2020

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White Paper: COVID-19 and The Great Acceleration of Digital Health

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White Paper: Smartphone Market Analysis for Software as a Medical Device (SaMD) Developers

White Paper

White Paper: FDA Software Precertification (Pre-cert): A Working Guide for Medical Device Companies

White Paper

White Paper: Software as a Medical Device (SaMD): What It Is & Why It Matters

eBook

EBook: Agile in an FDA Regulated Environment