(Total Views: 259)
Posted On: 10/15/2022 12:22:09 PM
Post# of 588
Interesting information or just a coincidence but...............
Webinar - Computer Software Assurance for Production and Quality System Software Draft Guidance
https://www.fda.gov/Medical-Devices
Select the software first square and you see the 10/27 webinar for production and software related guidance!
https://www.fda.gov/medical-devices/workshops...e-10272022
"The FDA believes that applying a risk-based approach to computer software used as part of medical device production or the quality system would better focus manufacturers' assurance activities to help ensure product quality while helping to fulfill the validation requirements of 21 CFR 820.70(i)."
Timing is everything!
JMO this may be spot on for our current FDA request?
$5-$10++
Webinar - Computer Software Assurance for Production and Quality System Software Draft Guidance
https://www.fda.gov/Medical-Devices
Select the software first square and you see the 10/27 webinar for production and software related guidance!
https://www.fda.gov/medical-devices/workshops...e-10272022
"The FDA believes that applying a risk-based approach to computer software used as part of medical device production or the quality system would better focus manufacturers' assurance activities to help ensure product quality while helping to fulfill the validation requirements of 21 CFR 820.70(i)."
Timing is everything!
JMO this may be spot on for our current FDA request?
$5-$10++
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