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PANEL DISCUSSION: Cardiovascular Device Development and the Regulatory Process

Friday, April 17, 2015 - 10:30am to 12:30pm

Room 217 A

PANEL DISCUSSION: Cardiovascular Device Development and the Regulatory Process

Scope

Meeting of FDA and international standards and testing protocols constitutes an integral part of getting a medical device approved. In a global setting, region specific requirements mandated by the various regulatory bodies often tend to be confusing. This session is aimed at bringing together expertise from various cardiovascular fields like catheters, drug eluting stents, heart valves, vena cava filters, etc. to help gain a better understanding of the "real-world" development/regulatory process. It will include not only the regulatory process as a part of the discussion but a bulk of the discussion would also involve non-clinical testing for these various devices necessary to satisfy the regulatory bodies.

Oral Presentations

  • 297. Chirag Tilara, Medtronic, Inc.

  • 298. Emily Ho, Secant Medical

  • 299. Semih Oktay, CardioMed Device Consultants

  • 300. Craig Weinberg, Biomedical Device Consultants and Laboratories

  • 301. Paul Schmidt, Edwards Lifesciences

Speaker(s)

CardioMed Device Consultants
Edwards Lifesciences
Secant Medical
Biomedical Device Consultants and Laboratories
Medtronic Coronary and Structural Heart