Obtaining premarket clearance for medical devices can be a challenging task. However, it is somewhat less daunting when you start out with a solid understanding of what is expected by the FDA and how the review process works.
This audio conference provides an understanding of the technical requirements of 510k submissions, provide practical advice on preparation of the documents and give an overview of the options and strategies associated with obtaining premarket clearance for medical devices. The speaker also draws on her extensive experience to provide valuable insights for minimizing the pitfalls and common mistakes associated with these types of FDA submissions.
This audio conference is presented by Rebecca Pine of Eisner Safety Consultants. To learn more, visit www.fxconferences.com.
