• You’ve launched your new cardiac defibrillator into the market after getting PMA through the FDA. You soon find out that it’s now being used as an at-home device for monitoring patients too sick for an implantable defibrillator. You decide to update the intended use. List 5 documents you will need to update and explain them.

  
  

 

Answer rating: 100% (QA)

Updating Documents for New Intended Use of Cardiac Defibrillator Shifting your new defibrillators intended use from implanted to athome monitoring requires careful documentation updates to ensure regu... View the full answer