Medical Devices – USA, Europe, Asia and ROW Regulatory News – Sept 2025
USA
Final Guidance: Computer Software Assurance
FDA released its long-awaited final guidance on Computer Software Assurance (CSA), replacing Section 6 of the 2002 software validation guidance....
CSA software validation, eSTAR submissions, EU MDR, FDA guidance, Global Regulatory News, Health Canada, Medical Device Compliance, medical device cybersecurity, Medical Device Regulations, MHRA clinical investigations, TGA