Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

Join us for a webinar on October 08 for a discussion of the webinar 

We will teach you how to design, build and test medical device software in preparation for the successful 510k submissions. It will cover medical device software user requirements, software architecture, design, unit testing and more.

Why Should You Attend

This webinar is essential for medical device companies interested in submitting software enabled medical devices or software as a medical device to the FDA for 510K approval. One of the biggest risks most company's face when submitting their device for approval is finding out after seven or more months of waiting that the 510K has been denied because the software portion of the submittal is inadequate and not compliant.

This webinar will ensure that device companies will know exactly what documentation needs to be prepared so the software portion of the submittal will be in compliance preventing delays of the 510K approval.

Companies can also face potential audit risks and serious findings post submittal that can block their ability to ultimately sell their product successfully. This course will ensure that you know what is expected to have in place for compliance for your company during the preparation of a 510K to prevent this risk.

Who will Benefit

  • Software developers and managers
  • Internal auditors
  • Quality Assurance personnel and management
  • Software quality personnel
  • Software test personnel
  • Regulatory affairs personnel and management
  • IT managers and system administrators
  • Software validation engineers

Industries who can attend

This 60-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel


Faculty Nancy Knettell

Faculty Nancy Knettell

Nancy Knettell, Founder and Principal at Software510, LLC, has over 30 years in combined Mechanical Design, Software Development, and Regulatory experience primarily in the Medical Device industry for such major medical device companies such as Smith and Nephew, Philips Medical, CR Bard, Kollsman Medical, Deka Research, Becton Dickenson, and Johnson and Johnson.

Choose a Purchase Options

$229

Live Webinar - Single Participant 60-mins

Recorded Access Included Free for 6 month

You get one log-in for the live 60-minute webinar for one participant, presentation materials and the opportunity to ask questions by phone and email

$399

Group Up to 5 Participants

You get 5 log-in for the live 60-minute webinar for all the participant, presentation materials and the opportunity to ask questions by phone and email


$289

Recorded Access Single - 6 month Access

You'll have access to one log-in for an archived recording of the entire 60-minute webinar, including the Q&A period, for 1 participant. You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately 48 hours after the session


$389

Training DVD

Within 48 hours delivered - Lifetime Access ,Audio recording of a webinar and reference manual delivered by download. Listen anytime on any compatible device.


$399

Live + Recorded Access

You get one log-in for the live & recorded 60-minute webinar for one participant, presentation materials and the opportunity to ask questions by phone and email