Software Quality Assurance For Medical Devices

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/computer-software-assurance-production-and-quality-system-software

Describe various methods and testing activities that may be applied to establish computer software assurance and provide objective evidence to fulfill regulatory requirements, such as computer...

https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-computer-software-assurance-production-and-quality-system-software-draft-guidance-10272022

Medical Software Testing and Quality Assurance in …

https://tateeda.com/blog/medical-software-testing-and-quality-assurance-in-medicine

Healthcare software quality assurance benefits the healthcare industry in a number of ways: Ensures the seamless operation of all medical software solutions, …

FDA Issues Draft Guidance on Computer Software Assurance for …

https://www.medtechintelligence.com/news_article/fda-issues-draft-guidance-on-computer-software-assurance-for-medical-devices/

The new guidance is intended to establish confidence in automation used for production or quality assurance systems and describe various methods and testing …