Design Controls Module 5:
Software Validation

Software validation is a critical element to ensure that your device is meeting the user’s requirements.. Is your validation process meeting FDA requirements?  This 1.5-hour webinar includes challenging software validation issues. Topics include:

  • Software validation vs. verification
  • What criteria make software a medical device and where do you draw the line?
  • Validation for manufacturing and process software – differences in regulatory requirements
  • Commercial off-the-shelf software:  Are you using a good testing strategy?
  • Real cases where development methods lead to robust software: technologies inside and outside of the medical device industry
  • Unresolved anomalies in software development

Expert Faculty

Pat Baird
Product Design Owner
Baxter Healthcare

Richard Chapman
Chief, General Hospital Devices Branch in the Office of Device Evaluation (ODE) of the Center for Devices and Radiological Health

(Expert faculty titles and companies may have changed since the time of recording.)



Learning Impact

Upon completion of this training, participants will:

  • Gain working knowledge of Design Control requirements across the Total Product Lifecycle (TPLC)
  • Understand the interdependencies across functional responsibilities on successful product design and launch
  • Get an overview of key regulations and guidances
  • Obtain Design Controls Professional Certificate (if all 10 webinar courses are viewed and certificate exam passed)


Certificate of Completion: Each participant will receive a Certificate of Completion for .1 CEUs upon viewing the webinar course and returning a completed evaluation form.

Professional Certificate: Each participant who views all 10 webinar modules and successfully passes the final exam will receive a Professional Certificate (1.0 CEU) from Xavier University. The final exam can be taken remotely after the last module.


$99 per module
$840 for entire series (Receive a 15% discount for purchasing all 10 modules)