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Medical device development runs from concept through design controls, verification and validation, clinical investigations when needed,...

FDA requires packaging that protects devices from alteration or damage  through processing, storage, handling, and distribution ( 21 CFR...

Medical device development costs vary by classification: Class I ($200K-$2M), Class II ($2M-$30M), and Class III ($5M-$119M+). Major expenses include clinical trials (40-60% of budget), regulatory activities (10-15%), manufacturing setup (15-25%), and commercialization (10-20%). Timeline spans 1-7 years depending on complexity and pathway. The #1 question every medtech entrepreneur asks: "How much funding do I actually need?" The answer depends on your device classification,

In the US, reimbursement for medical devices rests on three pillars: coding , coverage , and payment . Coding assigns CPT/HCPCS  and,...

FDA Design Controls under 21 CFR 820.30 are quality system requirements ensuring medical devices are designed to meet user needs and...

UDI  is FDA’s Unique Device Identification  system: most device labels and packages  must carry a UDI  in machine-readable (AIDC)  and...