FDAnews Announces — How to Achieve 510(k) Application Success for Device Software: Avoid Pitfalls that Could Delay Your Market Entry Webinar, June 30, 2014

Learn what devicemakers need to do to pass their 510(k) submission the first time and avoid costly delays that can wreak havoc on business. Join FDAnews and regulatory affairs expert Cheryl Wagoner on June 30, 2014 for an invaluable 90-minute webinar, How to Achieve 510(k) Application Success For Device Software: Avoid Pitfalls that Could Delay Your Market Entry that will clear up any confusion regarding an application for devices that contain software.

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FDAnews

FDAnews

Falls Church, VA (PRWEB) June 23, 2014

How to Achieve 510(k) Application Success for Device Software:
Avoid Pitfalls that Could Delay Your Market Entry
**FDAnews Webinar**
June 30, 2014 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/510kDeviceSoftware

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 devicemakers need to do to pass their 510(k) submission the first time and avoid costly delays that can wreak havoc on business.

Join FDAnews and regulatory affairs expert Cheryl Wagoner on June 30, 2014 for an invaluable 90-minute webinar, How to Achieve 510(k) Application Success For Device Software: Avoid Pitfalls that Could Delay Your Market Entry that will clear up any confusion regarding the application for devices that contain software.

Calling on her 20 years of experience, Ms. Wagoner will take attendees by the hand and walk them calmly, carefully and expertly through the steps needed to take to move the application forward as quickly as possible. Attendees will learn answers to key questions, such as:

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

Most importantly, attendees take home Ms. Wagoner’s all-inclusive checklist of items that must be included in the application; items that will help ensure the software section of the 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 the submission has been rejected and back to square one.

Instead, turn to an acknowledged expert whose experience, and checklist will take the guesswork out of the 510(k) application process. Attend How to Achieve 510(k) Application Success For Device Software: Avoid Pitfalls that Could Delay Your Market Entry on June 30, 2014.

Meet the Presenter:
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.

Who Will Benefit:

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

Webinar Details:
How to Achieve 510(k) Application Success for Device Software:
Avoid Pitfalls that Could Delay Your Market Entry
**FDAnews Webinar**
June 30, 2014 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/510kDeviceSoftware    

Tuition:
$487 per site -- includes webinar registration and audio cds and transcripts

Easy Ways to Register:
Online:     http://www.fdanews.com/510kDeviceSoftware    
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.