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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...

The Safe Medical Devices Act of 1990  amended the FD&C Act and reshaped US postmarket controls. It created mandatory user-facility MDR...