Learn best practices from these distinguished speakers:

  • Marjorie Shulman
    Consumer Safety Officer
    FDA
  • Peter Scott
    Divisional Director, Regulatory Affairs
    Abbott Point of Care
  • Joel Kent
    Manager, Regulatory Affairs
    GE Health Care
  • Steven Peltier
    Vice President, Regulatory Affairs
    Integra LifeSciences
  • Robert Steele
    Vice President, Regulatory Affairs and Quality (Compliance Officer)
    Stryker Medical
  • Heather Guerin
    Regulatory Affairs Specialist
    Synthes
  • Marybeth Gamber
    Principal Consultant, Regulatory Affairs
    Boston Biomedical
  • Albert Misajon
    Vice President, Regulatory Affairs & Quality Assurance
    Access Scientific
  • Steven Goldberg
    Regulatory Affairs Manager
    Siemens Healthcare Diagnostics

Develop Practical and Intellectual Knowledge of 510(k) Guidelines to Successfully Launch Your Products to Market

Approvals and Clearances for Medical Devices conference will provide you with the knowledge and strategies to stay on top of the continuously evolving FDA guidelines. Last year, there were 700 incidents of MDR’s and 10 deaths. Consequently, FDA is becoming more stringent on these regulations. There’s too much at stake for you to miss this inaugural medical device approval event. Avoid risk, avoid recalls, and get your products to market quickly and cost effectively.

At Approvals and Clearances for Medical Devices you will:

  • Gain intellectual knowledge of the 510(k) guidelines through proper communication with the FDA
  • Analyze and share details of the regulatory and classification process – explore intricacies of Class I, Class II, and Class III devices
  • Speed up the approval process and ensure stronger product claims and positive reimbursement
  • Perform risk analysis to ensure safety with current guidelines without compromising innovation
  • Implement tactful strategies for time management throughout the product life cycle

You will network and share experiences with V.P.’s, Directors, Managers, Specialists and Consultants of:

  • Regulatory Affairs
  • Corporate Affairs
  • Quality Assurance
  • Clinical Affairs
  • Quality Affairs
  • Quality Control
  • Regulatory Compliance

Testimonials

“I’m looking forward to sharing best practices, improving my network and learning from other experts and my peers.”
– Siemens Healthcare
“One of the best conferences I have attended.”
- QA Associate Director, Johnson & Johnson
“…very informative, with a good pace and a nice amount of time for networking and speaking to others working in the field.”
- Chief of Research, NIMH
“Simple enough to a beginner, complex enough for the experienced. Brilliant!”
- Senior Safety Officer, GSK
Major Sponsor
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