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The Benefits of a Breakthrough: The Advantages of FDA Breakthrough Designation for Patients and Medical Device Manufacturers

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Beyond the CE Mark: How to Collect Clinical Evidence to Ensure EU MDR Compliance

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Navigating the Pre-Market EU MDR Journey

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China: NMPA and the New Medical Device Regulations

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Global Regulatory Update: A Trend towards Harmonization and Enforcement

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The What, When, and How of Clinical Registries

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Environmental and Social Considerations for Medical Devices

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

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Changes to Medical Device Regulations in China

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What is an ICER and Why Should You Care?

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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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    • Testimonials
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      • Biostatistics
      • Data Visualization
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      • Field Support
      • Clinical Safety Management
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    • 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
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    • COVID-19
  • Resources
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