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USA

Blog

The Right Road to Approval: The Pros and Cons of
3 Regulatory Pathways

December 23, 2022

White Paper

Path to Approval: Why the FDA Q-Submission Program Is a Key Regulatory Strategy Component

White Paper

How to Use Data Visualization to Improve Clinical Trial Efficiency and Drive Business Value

Blog

5 Steps to Get Medicare Coverage for Your IDE Clinical Trial

June 18, 2021

White Paper

CMS Coverage Playbook: How to Secure IDE Clinical Trial Reimbursement White Paper

Blog

Post-market surveillance under a “522 order” — why, what, and how?

April 9, 2020

Blog

Have You Considered an EUA for Your Diagnostic Test?

April 2, 2020

Blog

Is the FDA’s EFS Program Right for Your Medical Device?

February 28, 2020

White Paper

Environmental and Social Considerations for Medical Devices

White Paper

Final FDA Guidance – Post-Market Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act

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About Avania

Avania is an integrated global, full-service CRO with specialized expertise in medical device, novel technology, and combination products. They advance products from feasibility all the way through post-approval trials in analytics, clinical trials, consulting, regulatory, reimbursement, and more.

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  • It Takes Avania
    • Our History
    • Global Reach
    • Leadership Team
    • Mission, Vision, & Values
    • Testimonials
  • Services
    • Analytics
      • Biostatistics
      • Data Visualization
    • Clinical Trials
      • Field Support
      • Clinical Safety Management
    • Consulting
    • Medical Writing
    • Quality Management
    • Regulatory
    • Reimbursement
  • Solutions
    • Therapeutic Expertise
      • Aesthetics
      • Cardiovascular
      • Dermatology
      • Neurology
      • Ophthalmology
      • Orthopedics
      • Urology
    • Industry Expertise
      • Medical Device
      • Medical Technology
      • In Vitro Diagnostics
      • Biotech
    • Specialized Expertise
      • FIH and EFS
      • CER
      • Data Visualization
    • Strategic Service Provider
  • News & Events
    • News
    • Events
    • COVID-19
  • Resources
  • Blog
  • Visit Our Virtual Booth
  • COVID-19
  • Careers
  • Contact