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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?

Your product is important, and your trial deserves the team that has what it takes. It takes knowledge. It takes passion. It takes commitment. It Takes Avania.

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