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510(k) Update – How to Format Succinct and Comprehensive 510(k)s – 3 Hours Virtual Seminar
This Webinar is over| Date | Nov 7, 2018 |
| Time | 03:00 PM EDT |
| Cost | $400.00 |
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Online
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This seminar will discuss what to consider and how to prepare for premarket notification 510(k)s and submit to the FDA. The speaker will walk you through how to format a succinct and comprehensive 510(k) package to increase submission quality and to facilitate the review process in a streamlined manner.
Why You Should Attend:
A premarket notification [PMN or 510(k)] is the most common regulatory pathway to bring some medical devices into the US market.
The 510(k) application is submitted to the US Food and Drug Administration (FDA) to demonstrate that the subject device (to be marketed) is substantially equivalent (as least as safe and effective) to a legally marketed device (predicate device).
Who Should Attend:
Why You Should Attend:
A premarket notification [PMN or 510(k)] is the most common regulatory pathway to bring some medical devices into the US market.
The 510(k) application is submitted to the US Food and Drug Administration (FDA) to demonstrate that the subject device (to be marketed) is substantially equivalent (as least as safe and effective) to a legally marketed device (predicate device).
Who Should Attend:
- Pharmaceutical Quality Departments
- Medical Devices Quality Departments
- Regulatory Affairs Departments
- Pharmaceutical Compliance Departments
- Medical Devices Compliance Departments
- CEOs
- VPs
- Attorneys
- Clinical Affairs Departments
- R&D Departments
- Consultants
- Contractors/Subcontractors
- Everyone responsible or Interested in the 510(k) Matters
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