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Top 5 FDA considerations for medtech-enabled data platforms
Medtech companies should have a team of FDA advisors at the ready to develop and implement pre- and post-market strategies, prevent and resolve pre- or post-market issues and guide lifecycle management
Risk categorization for software
Ai device software functions draft guidance
Categorization of digital health products
Clinical decision support software final guidance
Digital health products
Regulatory concerns
Based medical devices
Decision support software
Final guidance
Premarket submissions
Device software functions
Draft guidance
Medical devices
Quality system considerations
Medical device
Submission recommendations
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