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  • Regulations + Reimbursement Roundup (Module 2)

Paid Module

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Startup

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Regulations + Reimbursement Roundup

An essential piece of the Medical Alley Startup Method is learning about the many regulations you will face while building your health tech company. This module highlights information about FDA regulations and healthcare product reimbursement. You’ll learn about medical device classes, coding, coverage, and payment concepts. You’ll gain insights into your regulatory pathway and learn potential reimbursement options.

By the end of this module you'll be able to:

  • Identify FDA regulatory pathways (510k, De Novo, PMA) and key questions to determine the right pathway.
  • Explain the reimbursement process for health technologies, including coding, coverage, and payment.
  • Distinguish between Medicare, Medicaid, and commercial payers and their impact on reimbursement.
  • Explore regulatory and reimbursement resources.
  • Connect with Medical Alley experts for guidance and support.
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