FDA Issues Updated Guidance on Computer Software Assurance for Production and QMS Software
The FDA has issued an updated guidance on Computer Software Assurance for production and quality management system software, aligned with the new QMSR and ISO 13485.
FDA Issues Updated Final Guidance on Cybersecurity in Medical Devices
FDA issues final guidance on cybersecurity in medical devices, outlining QMS, premarket documentation, and Section 524B requirements for manufacturers.
MDCG 2025-10: Strengthened expectations for PMS systems under MDR and IVDR
New MDCG guidance on post-market surveillance provides clearer operational expectations for manufacturers under MDR and IVDR. PMS plans must now be more proactive, structured, and integrated into the QMS.