Successful 510(k) submission: Contents and Format 2012

  • 26 Sep 2012
  • Webinar

Description

Successful 510(k) submission: Contents and Format 2012 is a webinar that covers topics such as:

  • How to identify a predicate device(s), if any
  • Applicable Statute(s) and regulations for 510(k)s
  • Recent changes in the 510(k) program
  • How to demonstrate substantial equivalence
  • Differences in contents of 510(k)s based on products
  • Decision points during 510(k) review
  • How to address the relevant and applicable regulatory requirements
  • How to identify regulatory requirements relevant and applicable to the product(s)
  • How to increase 510(k) submission quality for a product
  • How to present your performance data and clinical data in a succinct, comprehensive manner

Successful 510(k) submission: Contents and Format 2012 brings together:

  • Clinical Affairs Managers, Directors and VPs
  • Regulatory Affairs Managers, Directors and VPs
  • Quality Managers, Directors and VPs
  • Quality Managers, Directors and VPs
  • Sales and Marketing Managers, Directors, and VPs
  • Compliance Managers and Directors
  • Site Managers, Directors, and Consultants
  • Complaint Handling and Risk Management Managers and Directors
  • Compliance Officers and Legal Counsel
  • Senior and Executive Management
  • Business Development Managers, Directors, and VPs

Past Events

Important

Please, check "Successful 510(k) submission: Contents and Format" official website for possible changes, before making any traveling arrangements

Event Categories

Health & Medicine: Healthcare, Medical laboratories, Medical technology, Pharma

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