Links & Resources

Resources

• 35 Years of FDA Approved Heart Valve Data

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  35 Years of FDA Approved Heart Valve Data

  To celebrate 35 years of FDA approved heart valves and to help our clients and partners learn from previous evaluations, we've compiled a list of 24 approved valves from FDA data, including summaries of their safety and effectiveness from the FDA website. Please provide your name, company name and email address to get your copy today.

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• Best Practices for Fatigue Assessment of Heart Valve Devices

Standards and Regulatory Agencies

• U.S. Food and Drug Administration
• Office of Device Evaluation (ODE)
• Office of Combination Products
• Office of Orphan Products Development
• CDRH Databases
• CDRH Device Advice
• ASTM International (originally American Society for Testing and Materials)
• International Organization for Standardization
• CE Marking Medical Devices
• American National Standards Institute (ANSI)
• Association for the Advancement of Medical Instrumentation
• Clinical and Laboratory Standards Institute
• Best Practices for Fatigue Assessment of Heart Valve Devices

Professional Societies

• The American Association for Thoracic Surgery (AATS)
• The American College of Cardiology (ACC)
• The American Heart Association (AHA)
• The American Society of Mechanical Engineers (ASME-BED)
• The Asian Society for Cardiovascular and Thoracic Surgery
• The Biomedical Engineering Society (BMES)
• The European Association for Cardio-Thoracic Surgery
• The Heart Valve Society
• The Heart Valve Society of America
• The Society of Thoracic Surgeons
• Society for Biomaterials
• Clinical and Laboratory Standards Institute

Conferences

• AsiaPCR
• EuroPCR
• EACTS
• STS
• MD&M West
• MEDTEC Europe
• Transcatheter Cardiovascular Therapeutics (TCT)
• Trancatheter Valve Therapies

Reciprocal Links

• Bridgemed Solutions, Inc.
• United Biologics Inc.
• Wake Forest Innovations Preclinical Translational Services