White Papers

Thought Leadership on SaMD, DTx & Connected Device Systems

White Paper

Predetermined Change Control Plan (PCCP) for Class II SaMD Products Beyond AI/ML

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White Paper

Advancing Agile Practices Across SaMD Life Cycle

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White Paper

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

eBook

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

White Paper

Product Analytics for Software as a Medical Device (SaMD)

White Paper

Frequent Releases
Of Medical Devices

White Paper

Digital Health and SaMD Lessons Learned from 2020

White Paper

COVID-19 and The Great Acceleration of Digital Health

White Paper

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

White Paper

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

White Paper

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

eBook

Agile in an FDA Regulated Environment