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Healthcare & Medical RFP FAQ
Do I need FDA approval to sell medical devices to the government?
Yes, if your product is an FDA-regulated medical device. Government buyers require the same FDA clearances as commercial buyers. Additionally, products may need to be on GSA Schedule 65 (Medical Equipment) or available through VA's Federal Supply Schedule.
How do VA set-asides work for healthcare?
The VA has special set-aside rules under the Veterans First Contracting Program. SDVOSB and VOSB firms get priority on VA contracts. You must be verified through SBA's VetCert program (formerly VA CVE) to qualify.
What certifications help win healthcare contracts?
HIPAA compliance is essential for anything touching patient data. For health IT, FedRAMP authorization and HITRUST certification are increasingly valued. ISO 13485 is important for medical device manufacturers.
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