Newsletter V. 2025 Issue 4
November 2025 Newsletter – Building a firm foundation in risk management
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Starting Up Design Controls for SaMD
CLIENT Small Medical Startup (<10 employees) Company Stage: Developing digital health product (SaMD) CHALLENGES Client staff consisted of physicians and engineers who had no experience with medical devices and regulations Aggressive timeline for software development, testing, and FDA submission No quality system and no head of quality SOLUTION Used a staged implementation for quality system
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Video sequence MOCKUP
Training for xxx OUTLINE Module 1 Below is the video for Module 1 … Module 2 Quiz Test your understanding of the material covered in Modules 1-n.
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