Unveiling FDA's new Computer Software Assurance: What Lies Beneath the Surface!

#FDA #csv #validation In the previous year, the FDA unveiled a novel methodology for validating computerized systems in medical device production and quality systems, known as Computer Software Assurance (CSA). Explore how this stands apart from the conventional Computer System Validation (CSV) method. How might you adapt your current processes in light of these changes? Additionally, what benefits can you expect from transitioning to CSA? Presented by: Peter Roka, MedTech Consultant, QUAREGIA Broadcasted during an Aligned AG "Sharpen your skills" event. Start a free trial: https://www.aligned.ch/free-trial Visit our website: https://www.aligned.ch Connect on Linkedin:   / aligned-ag