How to file a 510(k) when your device is (or contains) software

Speaker

Instructor: Cheryl Wagoner
Product ID: 703366
Training Level: Intermediate

Location
  • Duration: 75 Min
The Webinar will discuss the structure and level of detail required in filing a 510(k) when a medical device is software or contains software.
RECORDED TRAINING
Last Recorded Date: Apr-2014

 

$299.00
1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section
(For multiple locations contact Customer Care)

$499.00
Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days
(For multiple locations contact Customer Care)

 

 

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Why Should You Attend

In September 1999, FDA issued a guidance document entitled “Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices.” In May 2005, FDA issued another document entitled “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.”

Though these guidance documents are not new, there remains some confusion by industry regarding the use of software in medical devices. This webinar will attempt to provide some clarity. It will discuss the key elements required for a 510(k) application when the device contains software.

Areas covered in this webinar:

  • Define software use in medical devices. What makes your software a medical device?
  • Defining and supporting Level of Concern determination
  • What specific software –related documentation is required? How does the Level of Concern (LOC) determination impact this?
  • Risk Assessment/Mitigation and its relationship to the LOC
  • Software change management and its relationship to the LOC
  • V and V (Verification and Validation)
  • When is a 510(k) needed for Off the Shelf (OTS) software?
  • Could the Special 510(k) or Abbreviated 510(k) apply to your application?
  • Exemptions to the 510(k) requirements
  • Labeling of Software devices

Learning Objectives:

Upon completion of this session, attendees will understand the elements required for a 510(k) application when the device contains software.

Who Will Benefit:

  • Regulatory managers
  • Project managers
  • Regulatory specialists who compose 510(k) applications for software
  • Product Development managers
  • Documentation
  • Medical device IT/IS
  • CROs

Instructor Profile:

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.

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Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).

 

 

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