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Audio conference highlights

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, provides practical advice on preparation of the documents and gives 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 covers:

• The three different types of 510k
• Predicate devices and the concept of substantial equivalence
• Significance and consequences of intended use statements
• Content and formatting
• New requirements for certifications
• What to expect from the review process

About the speaker:

Rebecca Pine is a senior regulatory affairs and quality assurance consultant with Eisner Safety Consultants. She has over 18 years of experience in the medical device industry both at industry-leading corporations and small business start-ups. She began her career in documentation control and management before moving into regulatory affairs and subsequently regulatory consulting.

Her background includes all aspects of domestic and international medical device regulatory and quality management for a wide range of products including cardiovascular, orthopedic, electromedical devices, nuclear medicine and in vitro diagnostics (IVD). She has a Bachelor of Science degree with core competency in Biolgy and History, and is presently working towards a Juris Doctorate.

Who should attend?

• Regulatory Affairs Specialists
• Regulatory Affairs Managers
• Quality Assurance Managers
• Research & Development
• Product Engineering