How to Achieve 510(k) Application Success for Device Software

How to Achieve 510(k) Application Success for Device Software - Webinar CD/Transcript

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How to Achieve 510(k) Application Success for Device Software: Avoid Pitfalls that Could Delay Your Market Entry

With countless forms and steps necessary to get a medical device approved, many organizations become frustrated when a device is rejected from entering the market.  And then, the whole approval process starts all over again.

Learn what you need to do to pass your 510(k) submission the first time and avoid costly delays that can wreak havoc on your business.

Regulatory affairs expert Cheryl Wagoner clears up any confusion you may have regarding your application for devices that contain software in  How to Achieve 510(k) Application Success For Device Software: Avoid Pitfalls that Could Delay Your Market Entry webinar CD and transcript set.

Calling on her 20 years of experience, Cheryl takes you by the hand and walks you calmly, carefully and expertly through the steps you need to take to move your application forward as quickly as possible. You'll learn answers to key questions, such as:

  • What makes your software a medical device?
  • How do you define and support Level of Concern (LOC) determination?
  • What are the 11 software-related documentation sections you must include in your application?
  • How is Risk Assessment/Mitigation related to the LOC?
  • How is software change management related to the LOC?
  • Do you have to include V&V test reports?
  • What are two key exemptions from 510(k) requirements?
  • How do you meet labeling requirements (since there is no place to physically attach a label)?
  • And much more

Most importantly, you'll take home Cheryl's all-inclusive checklist of items you must include in your application … items that will help ensure the software section of your  510(k) is complete and reviewer friendly.

Put an end now to the frustration of spending endless hours filling out countless forms only to find that your submission has been rejected and you're back to square one.

Instead, turn to an acknowledged expert whose experience — and checklist —will take the guesswork out of your 510(k) application process.  

  • Device companies
  • Diagnostics companies
  • Device software developers
  • Finished device suppliers whose products contain software

Cheryl Wagoner has 20 years of experience in quality assurance and regulatory affairs. She currently is the Principal Consultant/Owner of Wagoner Consulting LLC, where she provides consulting services to medical device and pharmaceutical companies. Previously, she has held various positions in Quality, Regulatory, Clinical and Compliance in the medical device and pharmaceutical industries.

Cheryl is a member of Regulatory Affairs Professionals (RAPS), Association for the Advancement of Medical Instrumentation (AAMI), Medical Device Manufacturers (MDMA) FDA Working Group, and the MDMA Compliance Working Group. She completed the RAPS Executive Development Program at the Kellogg School of Management.