Tag: FDA guidance

Medical Devices – USA, Europe, Asia and ROW Regulatory News – Oct 2025

Medical Device

USA 1. Guidance on: Quality Management System Information for Certain Premarket Submission Reviews The guidance highlights the importance of submission of comprehensive, risk-based QMS documentation...

CDSCO India, EU MDR, FDA guidance, Global Regulatory News, MDA Malaysia, Medical Device Compliance, Medical Device Regulations, QMS, SaMD

Medical Devices – USA, Europe, Asia and ROW Regulatory News – Sept 2025

Medical Device

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